(169 days)
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 used for the nonsurgical removal of emboli and thrombi from arterial blood vessels in the peripheral vasculature, which is a direct therapeutic intervention to restore blood flow.
No
Explanation: The WOLF Thrombectomy Device is explicitly indicated for the "nonsurgical removal of emboli and thrombi," which is a treatment or therapy, not a diagnostic procedure to identify a disease or condition. While it uses radiopaque markers for visualization, this is for guidance during the interventional procedure, not for diagnosis.
No
The device description clearly outlines physical components like catheters, marker bands, and a weave, indicating it is a hardware device, not software-only.
Based on the provided information, the WOLF Thrombectomy Device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is the "nonsurgical removal of emboli and thrombi from arterial blood vessels in the peripheral vasculature." This describes a therapeutic intervention performed within the patient's body (in vivo).
- Device Description: The description details a mechanical device (catheters, weave) designed to physically remove clots from blood vessels. This is a procedural device, not a device used to examine specimens outside the body (in vitro).
- Anatomical Site: The device is used in "Arterial blood vessels in the peripheral vasculature," which are internal anatomical structures.
- Input Imaging Modality: Fluoroscopy is used for visualization during the procedure, not for analyzing a sample.
- Performance Studies: The studies described involve bench testing of the device's mechanical properties and animal testing to assess its safety and performance in vivo. There are no mentions of testing involving patient samples or diagnostic accuracy.
In Vitro Diagnostics (IVDs) are devices used to examine specimens, such as blood, urine, or tissue, that have been taken from the human body to provide information for diagnosis, monitoring, or screening. The WOLF Thrombectomy Device does not fit this definition.
N/A
Intended Use / Indications for Use
The WOLF Thrombectorny Device is indicated for the nonsurgical removal of emboli and thrombi from arterial blood vessels in the peripheral vasculature.
Product codes
DXE
Device Description
The WOLF Thrombectomy Device is comprised of two single lumen variable stiffness catheters (WOLF Inner & Outer) designed for use in removing clot from arterial peripheral vessels. The WOLF inner catheter is attached to the weave which when pulled, inqests the clot into the WOLF outer catheter. The WOLF device is delivered through a quide catheter that has an inner diameter of at least 0.068″. Both WOLF catheters have hydrophilic coating to facilitate tracking and reduce friction during ingestion of the clot.
The WOLF inner catheter has two radiopague marker bands. The distal marker is used to indicate the tip of the catheter during tracking. The proximal marker is used to indicate how far the physician should pull back the GC prior to pulling. The outer catheter has a distal radiopaque marker band to indicate its distal tip during tracking and pulling. The weave also has a radiopaque polymer cuff that allows for visualization of the weave movement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
arterial blood vessels in the 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)
Bench studies indicate that the 880 Medical WOLF Thrombectomy Device performs as intended. The following testing was performed in conformance with design inputs, including performance standards for peripheral vascular embolectomy devices. Testing included dimensional design verification/validation (durability and integrity, kink radius, torsion and tensile strength, air and liquid leak testing, clot retrievability, surface condition, coating integrity, particulate testing, corrosion resistance), sterilization validation, transit and package integrity testing, chronic animal safety testing, biocompatibility testing, simulated use testing, and comparative performance analysis with the predicate device. In addition, comparative testing of the INDIGO Aspiration Catheter was conducted in the simulated use test.
The WOLF Thrombectomy Device was subjected to acute and chronic animal study to compare the safety of the WOLF Device to a control device. The study was conducted per the US Food and Drug Administration, 21 CFR, Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies. The purpose of this study was to assess the angiographic damage to the target vessel on Day 28 and histopathological assessment of damage to the target vessel on Day 0 and Dav 28. The objectives, as well as the acceptance criteria for success, were met. No evidence of vessel dissection was seen acutely or through histopathology at the acute and chronic time points. When analyzed histologically, the treatment with the WOLF device resulted in equivalent or less endothelial erosion and mural injury as the control device. Acute injury was minimal and consistent with catheterization procedures. Vessel injuries were found to have healed completely and resulted in full re-endothelialization by the chronic time point (28 days).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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).
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March 27, 2019
880 Medical, LLC % Ms. Roberta Hines Regulatory Consultant Northwest Clinical Research Group, Inc. 19836 NE 125th Place Woodinville, WA 98077
Re: K182835
Trade/Device Name: WOLF Thrombectomy Device Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: February 19, 2019 Received: February 22, 2019
Dear Ms. 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
1
requirements, including, but not limited to: registration and listing (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 Eleni by Eleni Whatley Date: 2019.03.27 Whatley 13:17:55 -04'00' For
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182835
Device Name WOLF Thrombectomy Device
Indications for Use (Describe)
The WOLF Thrombectorny Device is indicated for the nonsurgical removal of emboli and thrombi from arterial blood vessels in the peripheral vasculature.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 201 Subpart D) | ☐ Over-The-Counter Use (21 CFR 201 Subpart C) |
|---|---|
| -------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for 880 Medical LLC. The logo consists of a circular graphic on the left and the text "880 Medical LLC" on the right. The circular graphic is a spiral design with a dark red center and lighter red lines spiraling outward.
510(k) SUMMARY 880 Medical, LLC WOLF Thrombectomy Device
K182835
General Company Information
| Name: | 880 Medical, LLC |
|---|---|
| Address: | 46714 Fremont Blvd. |
| Fremont, CA 94538, USA | |
| Contact: | Roberta Hines, Regulatory Consultant |
| Telephone: | 425-766-0308 |
| Email: | rhines@nwcrq.com |
Date Prepared
February 19, 2019
General Device Information
Product Name: WOLF Thrombectomy Device Common Name: Thrombectomy Catheter Classification: Catheter, Embolectorny (21 CFR 870.5150, Product Code: DXE)
Predicate Devices
| Inari Medical, Inc. | Inari Medical Infusion Aspiration Catheter System, also known
as the FlowTriever (K143563) (Primary) |
| --------------------- | --------------------------------------------------------------------------------------------------------- |
|---|
Reference Device
Penumbra, Inc. Penumbra Embolectomy Aspiration System (INDIGO Aspiration System) (K142870)
Description
The WOLF Thrombectomy Device is comprised of two single lumen variable stiffness catheters (WOLF Inner & Outer) designed for use in removing clot from arterial peripheral vessels. The WOLF inner catheter is attached to the weave which when pulled, inqests the clot into the WOLF outer catheter. The WOLF device is delivered through a quide catheter that has an inner diameter of at least 0.068″. Both WOLF catheters have hydrophilic coating to facilitate tracking and reduce friction during ingestion of the clot.
The WOLF inner catheter has two radiopague marker bands. The distal marker is used to indicate the tip of the catheter during tracking. The proximal marker is used to indicate how far the physician should pull back the GC prior to pulling. The outer catheter has a distal radiopaque marker band to indicate its distal tip during tracking and pulling. The weave also has a radiopaque polymer cuff that allows for visualization of the weave movement.
Indication for Use
The WOLF Thrombectomy Device is indicated for the nonsurgical removal of emboli and thrombi from arterial blood vessels in the peripheral vasculature.
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Image /page/4/Picture/0 description: The image contains a logo for 880 Medical LLC. The logo consists of a circular design on the left and the text "880 Medical LLC" on the right. The circular design features a series of curved lines that radiate outward from the center, creating a spiral effect.
Substantial Equivalence
The data presented in this submission demonstrates the technological similarity of the WOLF Thrombectory Device compared with the primary predicate device, the Inari Medical Infusion Aspiration Catheter System.
The devices have the same intended use (peripheral vascular), use the same mechanism of action, incorporate similar components, use similar construction and material, are compatible with a quide catheter/sheath and are packaged and sterilized using the same processes.
Both devices are coaxial systems consisting of an Inner catheter with a metallic/polymer composite, an Outer catheter with a metallic/polymer composite, and a nitinol Weave/Clot Grabbing structure attached to the distal end of the Inner catheter.
In addition to the primary predicate device, a reference device has been included in this submission to support substantial equivalence to a marketed device. The INDIGO Aspiration Catheter and Separator is considered as a reference device because it has the same intended use, same mechanisms of actions and its 5F device is used in similar sized vessels as the WOLF Thrombectomy Device.
Biocompatibility, performance testing, simulated use testing, and animal testing demonstrate that the device has appropriate properties for its intended use.
Performance Data
Bench studies indicate that the 880 Medical WOLF Thrombectomy Device performs as intended. The following testing was performed in conformance with design inputs, including performance standards for peripheral vascular embolectomy devices. Testing included dimensional design verification/validation (durability and integrity, kink radius, torsion and tensile strength, air and liquid leak testing, clot retrievability, surface condition, coating integrity, particulate testing, corrosion resistance), sterilization validation, transit and package integrity testing, chronic animal safety testing, biocompatibility testing, simulated use testing, and comparative performance analysis with the predicate device. In addition, comparative testing of the INDIGO Aspiration Catheter was conducted in the simulated use test.
Technical Comparison
The technical features of the WOLF Thrombectomy Device and the Inari FlowTriever device are the same or similar for both the design components and the mechanism of action. Both devices are also provided sterile and are sterilized by the same method (EO).
Both the WOLF Thrombectomy and Inari FlowTriever Device have four main design components, highlighting their similarities in design:
-
- Weave/Clot Grabber – attached to distal end of Inner Catheter
-
- Inner Catheter
-
- Outer Catheter
-
- Aspiration Source
Both devices are made of similar materials and come in similar configurations (shape, diameter and lengths). The Weave/Clot Grabber component in both devices is a tubular weave structure formed from nitinol wire and is attached to the distal end of the Inner Catheter. The Weave/Clot Grabber is the component that integrates into the clot and aids in clot removal. Also, for both devices the Inner and Outer Catheters are coaxial single lumen metallic/polymeric compositic coating. The aspiration source for both the WOLF Thrombectomy Device and the Inari FlowTriever is a syringe-based design.
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Image /page/5/Picture/0 description: The image shows the logo for 880 Medical LLC. The logo consists of a circular design with swirling lines on the left and the text "880 Medical LLC" on the right. The logo is in a maroon color.
Both the WOLF Thrombectomy Device and Inari FlowTriever Device are delivered through the femoral artery, provide delivery of contrast, and contain radiopague markers for visualization under fluoroscopy. Both devices are used with introducer sheaths/quide catheters and quidewires. The WOLF Thrombectorny Device has been tested for compatibility with the appropriate accessories in preclinical (animal) testing and simulated use design validation testing.
Biocompatibility Testing
The WOLF Thrombectomy Device was subjected to the following biocompatibility testing per the ISO-10993-1 standard: cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, pyrogenicity, hemocompatibility testing (partial thromboplastin time, assay for coagulation and hematology parameters, and hemolysis) and endotoxin testing. The results showed that the WOLF Thrombectomy Device meets biocompatibility requirements of the ISO standard.
Sterilization Validation
Sterilization validation testing verified with a high degree of assurance that Ethylene Oxide sterilization is effective in achieving sterility of the 880 WOLF Thrombectorny Device at a sterility assurance level of 10°.
Package Integrity After Aging and Distribution
Packaging was verified to protect the WOLF Thrombectomy Device adequately to ensure product function throughout the claimed shelf life and after exposure to the storage and distribution environment.
Animal Testing
The WOLF Thrombectomy Device was subjected to acute and chronic animal study to compare the safety of the WOLF Device to a control device. The study was conducted per the US Food and Drug Administration, 21 CFR, Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies. The purpose of this study was to assess the angiographic damage to the target vessel on Day 28 and histopathological assessment of damage to the target vessel on Day 0 and Dav 28. The objectives, as well as the acceptance criteria for success, were met. No evidence of vessel dissection was seen acutely or through histopathology at the acute and chronic time points. When analyzed histologically, the treatment with the WOLF device resulted in equivalent or less endothelial erosion and mural injury as the control device. Acute injury was minimal and consistent with catheterization procedures. Vessel injuries were found to have healed completely and resulted in full re-endothelialization by the chronic time point (28 days).
Conclusions
The WOLF Thrombectomy Device and its predicate device have the same intended use and similar technological characteristics. The differences do not raise different questions of safety or effectiveness. Performance testing further demonstrates that the device is substantially equivalent to the predicate for its intended use.