(51 days)
No
The device description and performance studies focus on mechanical and physical properties, with no mention of AI/ML algorithms or data processing for decision-making or analysis.
Yes
The device is indicated for "non-surgical removal of thrombi and emboli from blood vessels," which directly addresses a medical condition, making it a therapeutic device.
No
Explanation: The VenaCore Thrombectomy Catheter is described as a device for the non-surgical removal of thrombi and emboli from blood vessels. It is used for minimally invasive treatment, indicating a therapeutic rather than diagnostic purpose. Its function is to remove clots, not to identify or characterize medical conditions.
No
The device description clearly details physical components like a catheter, handle, knob, lever, and radiopaque tips, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This examination is performed outside of the living body (in vitro).
- VenaCore Thrombectomy Catheter Function: The VenaCore Thrombectomy Catheter is a surgical device used within the body (in vivo) to physically remove blood clots from blood vessels. It is a therapeutic device, not a diagnostic one that analyzes specimens.
The description clearly states its purpose is the "non-surgical removal of thrombi and emboli from blood vessels" and "Injection, infusion, and/or aspiration of contrast media and other fluids into or from blood vessels." These are all procedures performed directly on the patient's circulatory system, not on a sample in a lab.
N/A
Intended Use / Indications for Use
The VenaCore Thrombectomy Catheter is indicated for:
· The non-surgical removal of thrombi and emboli from blood vessels.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from blood vessels.
The VenaCore Thrombectomy Catheter is intended for use in the peripheral vasculature.
Product codes
QEW, KRA
Device Description
The VenaCore Thrombectomy Catheter is a single-use, sterile, over-the-wire catheter used for the minimally invasive treatment of thromboemboli in the peripheral vasculature. The VenaCore Thrombectomy Catheter is designed to remove thrombi and emboli in the peripheral vasculature. The VenaCore Thrombectomy Catheter consists of a distal laser-cut nitinol coring element, three coaxial catheter shafts (inner, middle, and outer), and a handle with a diameter control knob and a lever. The proximal handle controls the expansion and collapse of the coring element via the handle knob and lever. The outer shaft constrains the coring element prior to deployment. To aid in fluoroscopic visualization, the distal tip is radiopaque, and a radiopaque tip is located on the outer catheter to identify the distal end of the outer catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopic visualization
Anatomical Site
Peripheral vasculature, 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
Non-Clinical Testing: In accordance with the Design Failure Modes and Effects Analysis, verification and validation testing were identified to support the substantial equivalence of the VenaCore Thrombectomy Catheter to the predicate device. These tests included:
Design Verification Testing:
- Pouch Seal Visual Inspection
- Bubble Leak
- Dye Penetration
- Packaging Usability Evaluation for Aseptic Presentation
- Pouch Peel and Seal Strength
- Label Integrity
- Visual and Dimensional Inspection
- Deairing/Flushing
- Guidewire Compatibility
- Knob Torque Testing
- Handle Lever Testing
- VenaCore Element Deployment Force from Delivery Catheter
- VenaCore Element Retraction Force into Delivery Catheter
- VenaCore Distal Catheter Kink Radius
- VenaCore Element Durability Inspection
- VenaCore Delivery Catheter Durability Inspection
- Insertion of VenaCore Catheter through Sheath
- Advancement Force of VenaCore Catheter through Sheath
- Retraction Force of VenaCore Catheter through Sheath
- Leakage Test, Sheath
- Vacuum Test, Sheath
- Air Leakage, Sheath
- Leakage Test, VenaCore Catheter
- Tensile Testing, VenaCore Catheter
- Tensile Testing, Delivery Catheter
- Torque Testing, VenaCore Catheter
- Rotation Testing, VenaCore Delivery Catheter
- Corrosion Testing
- Particulate Matter Testing
- ISO 80369-7 and ISO 80369-20 Luer Testing Proximal Luer and Middle Catheter Luer
- Clot Removal Efficacy (Characterization Only)
- In Vivo Functional Testing/Radiopacity Verification
Key results: Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications.
Key Metrics
Not Found
Predicate Device(s)
Inari Medical, RevCore™ Thrombectomy Catheter (K223609)
Reference Device(s)
Not Found
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 logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is 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. The logos are simple and professional, and they are easily recognizable.
February 9, 2024
Inari Medical, Inc. Kaitlyn Weinkauf Sr. Regulatory Affairs Specialist 6001 Oak Canyon Suite 100 Irvine, California 92618
Re: K234034
Trade/Device Name: VenaCore™ Thrombectomy Catheter (46-101) Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, KRA Dated: December 20, 2023 Received: December 20, 2023
Dear Kaitlyn Weinkauf:
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 medical devices and radiation-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 W. Digitally signed by
Gregory W. Gregory W. O'connell -S O'connell -S 11:57:56-05'00'
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
2
Indications for Use
Submission Number (if known)
Device Name
VenaCore™ Thrombectomy Catheter (46-101)
Indications for Use (Describe)
The VenaCore Thrombectomy Catheter is indicated for:
· The non-surgical removal of thrombi and emboli from blood vessels.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from blood vessels.
The VenaCore Thrombectomy Catheter is intended for use in the peripheral vasculature.
Type of Use (Select one or both, as applicable)
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
PAGE 1 OF 5
510(K) SUMMARY
| Date prepared | February 9, 2024 |
|---|---|
| Name | Inari Medical, Inc. |
| 6001 Oak Canyon, Suite 100 | |
| Irvine, CA 92618 | |
| 877.923.4747 | |
| Contact person | Kaitlyn Weinkauf |
| Sr. Regulatory Affairs Specialist | |
| Trade name | VenaCore™ Thrombectomy Catheter (46-101) |
| Common name | Embolectomy Catheter |
| Regulation name | Embolectomy Catheter |
| Classification number | 21 CFR 870.5150 |
| Primary product code | QEW |
| Secondary product code | KRA |
| Regulatory class | II |
| Predicate device | Inari Medical, RevCore™ Thrombectomy Catheter (K223609) |
| Description | The VenaCore Thrombectomy Catheter is a single-use, sterile, over-the-wire |
| catheter used for the minimally invasive treatment of thromboemboli in the | |
| peripheral vasculature. The VenaCore Thrombectomy Catheter is designed | |
| to remove thrombi and emboli in the peripheral vasculature. The VenaCore | |
| Thrombectomy Catheter consists of a distal laser-cut nitinol coring element, | |
| three coaxial catheter shafts (inner, middle, and outer), and a handle with a | |
| diameter control knob and a lever. The proximal handle controls the | |
| expansion and collapse of the coring element via the handle knob and lever. | |
| The outer shaft constrains the coring element prior to deployment. To aid in | |
| fluoroscopic visualization, the distal tip is radiopaque, and a radiopaque tip | |
| is located on the outer catheter to identify the distal end of the outer catheter. | |
| Indications for Use | The VenaCore Thrombectomy Catheter is indicated for: |
| The non-surgical removal of thrombi and emboli from blood vessels. Injection, infusion, and/or aspiration of contrast media and other fluids into or from blood vessels. The VenaCore Thrombectomy Catheter is intended for use in the peripheral vasculature. |
4
A tabular comparison of the predicate and subject devices is provided below: Summary of substantial equivalence
| Subject Device | Predicate Device | |
|---|---|---|
| VenaCore Thrombectomy Catheter | RevCore Thrombectomy Catheter | |
| 510(k) Number | TBD | K223609 |
| Manufacturer | Inari Medical, Inc. | Inari Medical, Inc. |
| Regulation | 21 CFR 870.5150 Embolectomy catheter | 21 CFR 870.5150 Embolectomy catheter |
| Product Code | QEW, KRA | QEW |
| Intended Use | The VenaCore Thrombectomy | |
| Catheter is intended for use in the | ||
| peripheral vasculature for the removal | ||
| of thrombus and emboli from blood | ||
| vessels and the infusion of fluids into | ||
| blood vessels. | The RevCore Thrombectomy | |
| Catheter is intended for use in the | ||
| peripheral vasculature for the removal | ||
| of thrombus and emboli from blood | ||
| vessels and the infusion of fluids into | ||
| blood vessels. | ||
| Indications for Use | The VenaCore Thrombectomy | |
| Catheter is indicated for: | ||
| The non-surgical removal of | ||
| thrombi and emboli from | ||
| blood vessels.Injection, infusion, and/or | ||
| aspiration of contrast media | ||
| and other fluids into or from | ||
| blood vessels.The VenaCore Thrombectomy | ||
| Catheter is intended for use in the | ||
| peripheral vasculature. | The RevCore Thrombectomy | |
| Catheter is indicated for: | ||
| The non-surgical removal of | ||
| thrombi and emboli from | ||
| blood vessels.Injection, infusion, and/or | ||
| aspiration of contrast media | ||
| and other fluids into or from | ||
| blood vessels.The RevCore Thrombectomy | ||
| Catheter is intended for use in the | ||
| peripheral vasculature. | ||
| Device Description | The VenaCore Thrombectomy | |
| Catheter is a single-use, sterile, over- | ||
| the-wire catheter used for the | ||
| minimally invasive treatment of | ||
| thromboemboli in the peripheral | ||
| vasculature. The VenaCore | ||
| Thrombectomy Catheter is designed | ||
| to remove thrombi and emboli in the | ||
| peripheral vasculature. The VenaCore | ||
| Thrombectomy Catheter consists of a | ||
| distal laser-cut nitinol coring element, | ||
| three coaxial catheter shafts (inner, | ||
| middle, and outer), and a handle with | ||
| a diameter control knob and a lever. | ||
| The proximal handle controls the | ||
| expansion and collapse of the coring | ||
| element via the handle knob and | ||
| lever. The outer shaft constrains the | ||
| coring element prior to deployment. | ||
| To aid in fluoroscopic visualization, | The RevCore Thrombectomy | |
| Catheter is a single-use, sterile, over- | ||
| the-wire catheter used for the | ||
| minimally invasive treatment of | ||
| thromboemboli in the peripheral | ||
| vasculature, and within venous stents. | ||
| The RevCore Thrombectomy | ||
| Catheter consists of a distal laser-cut | ||
| nitinol coring element, three coaxial | ||
| catheter shafts (inner, middle, and | ||
| outer), and a handle with a diameter | ||
| control knob. The proximal handle | ||
| controls the expansion and collapse of | ||
| the coring element via the handle | ||
| knob. The middle and inner shaft | ||
| constrains the coring element prior to | ||
| deployment. To aid in fluoroscopic | ||
| visualization, the distal tip is | ||
| radiopaque, and a radiopaque tip is | ||
| located on the outer catheter to | ||
| the distal tip is radiopaque, and a | ||
| radiopaque tip is located on the outer | ||
| catheter to identify the distal end of | ||
| the outer catheter. | identify the distal end of the outer | |
| catheter. | ||
| Principles of | ||
| Operation | The coring element is composed of | |
| self-expanding nitinol and the | ||
| diameter is manually controlled by a | ||
| knob in the handle. The coring | ||
| element is retracted through the | ||
| vessel to engage and remove | ||
| thrombus and emboli. The device and | ||
| captured clot are removed from the | ||
| vessel through the introducer sheath. | The coring element is composed of | |
| self-expanding nitinol and the | ||
| diameter is manually controlled by a | ||
| knob in the handle. The coring | ||
| element is retracted through the vessel | ||
| to engage and remove thrombus and | ||
| emboli. The device and captured clot | ||
| are removed from the vessel through | ||
| the introducer sheath. | ||
| Catheter OD | 12 Fr | 12 Fr |
| Effective Length | 80 cm | 80 cm |
| Coring Element | ||
| Description | The VenaCore Thrombectomy | |
| Catheter element contains 6 nitinol | ||
| struts that pair off and connect in the | ||
| center to compose a series of | ||
| diamond cell patterns. | The RevCore Thrombectomy | |
| Catheter element contains 6 nitinol | ||
| struts that have a single connection | ||
| point on the distal and proximal end. | ||
| The element struts themselves are cut | ||
| in such a way that it retains some | ||
| features from the original laser cut | ||
| tubing, which is referred to as the | ||
| "wave." | ||
| Coring Element | ||
| Actuation | ||
| Mechanism | Knob and lever active diameter | |
| control. This is achieved by the | ||
| relative movement of the inner and | ||
| mid shaft. The inner shaft and mid | ||
| shaft work together to axially | ||
| compress or elongate the element, | ||
| which in turn expands/contracts the | ||
| element to the desired treatment | ||
| diameter. | Knob active diameter control. This is | |
| achieved by the relative movement of | ||
| the inner and mid shaft. The inner | ||
| shaft and mid shaft work together to | ||
| axially compress or elongate the | ||
| element, which in turn | ||
| expands/contracts the element to the | ||
| desired treatment diameter. | ||
| Element Material | Nitinol laser cut hypotube | Nitinol laser cut hypotube |
| Inner Catheter | ||
| Material | Nitinol hypotube | Nitinol hypotube |
| Middle Catheter | ||
| Material | Nitinol Hypotube | |
| 316L Stainless Steel | ||
| 18-8 Stainless Steel | Pebax 35D, Cool Grey 8C | |
| 304V Stainless Steel | ||
| 316 Stainless Steel | ||
| Outer Catheter | ||
| Material | Pebax 72D, Cool Grey 4C | |
| Pebax 72D, Violet C | ||
| 316 stainless steel | ||
| 304V stainless steel | Pebax 63D, Cool Grey 4C | |
| Pebax 63D, Violet C | ||
| Pebax 55D, Violet C | ||
| PTFE Liner | ||
| 90% Platinum / 10% Iridium Split | ||
| Marker Band | ||
| 304V stainless steel | ||
| Target Vessel | Peripheral vessels 6-16 mm | Peripheral vessels 6-20 mm |
5
K234034
6
| Shelf-life | 6 months | 24 months |
|---|---|---|
| Guidewire | ||
| compatibility | 0.035" | 0.035" |
| Single use | Yes | Yes |
Summary of substantial equivalence
Biocompatibility
The following biocompatibility tests were completed for the subject device:
- Cytotoxicity
- Sensitization ●
- . Intracutaneous Reactivity
- Acute Systemic Toxicity
- Material-Mediated Pyrogenicity
- . Hemocompatibility (Hemolysis. Complement Activation. Thromboresistance, Platelet and Leukocyte Count, and Partial Thromboplastin Time)
The results demonstrate that the subject device meets biological safety requirements per ISO 10993-1:2018.
Sterilization
The subject device, including its accessories, is sterilized using EtO to achieve a sterility assurance level (SAL) of 10 ° using a validated sterilization process in accordance with the principles of ISO 11135:2014/Amd 1:2018 and AAMI TIR28:2016.
Non-Clinical Testing
In accordance with the Design Failure Modes and Effects Analysis, verification and validation testing were identified to support the substantial equivalence of the VenaCore Thrombectomy Catheter to the predicate device. These tests included:
Design Verification Testing
- Pouch Seal Visual Inspection
- Bubble Leak ●
- Dye Penetration ●
- Packaging Usability Evaluation for Aseptic Presentation ●
- Pouch Peel and Seal Strength ●
- Label Integrity ●
- Visual and Dimensional Inspection
- Deairing/Flushing ●
- Guidewire Compatibility
- Knob Torque Testing
- Handle Lever Testing ●
- VenaCore Element Deployment Force from Delivery Catheter
- VenaCore Element Retraction Force into Delivery Catheter ●
- VenaCore Distal Catheter Kink Radius ●
- VenaCore Element Durability Inspection ●
- . VenaCore Delivery Catheter Durability Inspection
7
K234034
PAGE 5 OF 5
- Insertion of VenaCore Catheter through Sheath ●
- Advancement Force of VenaCore Catheter through Sheath ●
- Retraction Force of VenaCore Catheter through Sheath
- Leakage Test, Sheath
- Vacuum Test, Sheath .
- Air Leakage, Sheath ●
- Leakage Test, VenaCore Catheter ●
- Tensile Testing, VenaCore Catheter
- Tensile Testing, Delivery Catheter
- . Torque Testing, VenaCore Catheter
- Rotation Testing, VenaCore Delivery Catheter
- . Corrosion Testing
- Particulate Matter Testing ●
- ISO 80369-7 and ISO 80369-20 Luer Testing Proximal Luer and ● Middle Catheter Luer
- Clot Removal Efficacy (Characterization Only) ●
- In Vivo Functional Testing/Radiopacity Verification ●
Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications.
Clinical testing was not required for the determination of substantial equivalence.
Conclusion
VenaCore Thrombectomy Catheter has the same The intended use/indications for use and principles of operation as the predicate. Nonclinical performance data show that the different technological characteristics between the devices do not raise any new or different questions of safety or effectiveness and support the VenaCore Thrombectomy Catheter's substantial equivalence to the predicate device.