(51 days)
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 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.
This looks like a 510(k) submission for a medical device called the "VenaCore Thrombectomy Catheter." The provided text describes the device, its intended use, and a comparison to a predicate device. It also details the non-clinical testing performed to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study information based only on your provided text:
1. A table of acceptance criteria and the reported device performance
The document states, "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications." However, the specific quantitative acceptance criteria for each test and the corresponding reported device performance values are not provided in the text. The document lists the types of tests performed but not the pass/fail thresholds or the numerical results.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document lists "Non-Clinical Testing" which means these were laboratory or bench tests, not tests on human subjects. Therefore, terms like "test set," "data provenance," "country of origin," and "retrospective or prospective" are not applicable in their usual clinical sense. The specific sample sizes for each non-clinical test (e.g., how many catheters were tested for tensile strength) are not detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable. The testing described is non-clinical (bench testing), not a clinical study involving expert assessment of patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods are typically used in clinical studies where multiple human readers assess data and discrepancies need to be resolved. This document describes non-clinical engineering and material property testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done. The document explicitly states: "Clinical testing was not required for the determination of substantial equivalence." Furthermore, this is a thrombectomy catheter, not an AI-powered diagnostic device, so the concept of AI assistance for human readers is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a mechanical thrombectomy catheter, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests, the "ground truth" would be established engineering specifications, material standards (e.g., ISO standards), and physical measurements. For example, for "Tensile Testing," the ground truth would be defined by a maximum allowable force before breakage according to the design specification. The specific standards or target values are not explicitly given in the text.
8. The sample size for the training set
This question is not applicable. The device does not involve machine learning or AI models that require a training set.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as point 8.
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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).
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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
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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)
< | Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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PAGE 1 OF 5
510(K) SUMMARY
| Date prepared | February 9, 2024 |
|---|---|
| Name | Inari Medical, Inc.6001 Oak Canyon, Suite 100Irvine, CA 92618877.923.4747 |
| Contact person | Kaitlyn WeinkaufSr. 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-wirecatheter used for the minimally invasive treatment of thromboemboli in theperipheral vasculature. The VenaCore Thrombectomy Catheter is designedto remove thrombi and emboli in the peripheral vasculature. The VenaCoreThrombectomy Catheter consists of a distal laser-cut nitinol coring element,three coaxial catheter shafts (inner, middle, and outer), and a handle with adiameter control knob and a lever. The proximal handle controls theexpansion and collapse of the coring element via the handle knob and lever.The outer shaft constrains the coring element prior to deployment. To aid influoroscopic visualization, the distal tip is radiopaque, and a radiopaque tipis 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. |
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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 ThrombectomyCatheter is intended for use in theperipheral vasculature for the removalof thrombus and emboli from bloodvessels and the infusion of fluids intoblood vessels. | The RevCore ThrombectomyCatheter is intended for use in theperipheral vasculature for the removalof thrombus and emboli from bloodvessels and the infusion of fluids intoblood vessels. |
| Indications for Use | The VenaCore ThrombectomyCatheter is indicated for:The non-surgical removal ofthrombi and emboli fromblood vessels.Injection, infusion, and/oraspiration of contrast mediaand other fluids into or fromblood vessels.The VenaCore ThrombectomyCatheter is intended for use in theperipheral vasculature. | The RevCore ThrombectomyCatheter is indicated for:The non-surgical removal ofthrombi and emboli fromblood vessels.Injection, infusion, and/oraspiration of contrast mediaand other fluids into or fromblood vessels.The RevCore ThrombectomyCatheter is intended for use in theperipheral vasculature. |
| Device Description | The VenaCore ThrombectomyCatheter is a single-use, sterile, over-the-wire catheter used for theminimally invasive treatment ofthromboemboli in the peripheralvasculature. The VenaCoreThrombectomy Catheter is designedto remove thrombi and emboli in theperipheral vasculature. The VenaCoreThrombectomy Catheter consists of adistal laser-cut nitinol coring element,three coaxial catheter shafts (inner,middle, and outer), and a handle witha diameter control knob and a lever.The proximal handle controls theexpansion and collapse of the coringelement via the handle knob andlever. The outer shaft constrains thecoring element prior to deployment.To aid in fluoroscopic visualization, | The RevCore ThrombectomyCatheter is a single-use, sterile, over-the-wire catheter used for theminimally invasive treatment ofthromboemboli in the peripheralvasculature, and within venous stents.The RevCore ThrombectomyCatheter consists of a distal laser-cutnitinol coring element, three coaxialcatheter shafts (inner, middle, andouter), and a handle with a diametercontrol knob. The proximal handlecontrols the expansion and collapse ofthe coring element via the handleknob. The middle and inner shaftconstrains the coring element prior todeployment. To aid in fluoroscopicvisualization, the distal tip isradiopaque, and a radiopaque tip islocated on the outer catheter to |
| the distal tip is radiopaque, and aradiopaque tip is located on the outercatheter to identify the distal end ofthe outer catheter. | identify the distal end of the outercatheter. | |
| Principles ofOperation | The coring element is composed ofself-expanding nitinol and thediameter is manually controlled by aknob in the handle. The coringelement is retracted through thevessel to engage and removethrombus and emboli. The device andcaptured clot are removed from thevessel through the introducer sheath. | The coring element is composed ofself-expanding nitinol and thediameter is manually controlled by aknob in the handle. The coringelement is retracted through the vesselto engage and remove thrombus andemboli. The device and captured clotare removed from the vessel throughthe introducer sheath. |
| Catheter OD | 12 Fr | 12 Fr |
| Effective Length | 80 cm | 80 cm |
| Coring ElementDescription | The VenaCore ThrombectomyCatheter element contains 6 nitinolstruts that pair off and connect in thecenter to compose a series ofdiamond cell patterns. | The RevCore ThrombectomyCatheter element contains 6 nitinolstruts that have a single connectionpoint on the distal and proximal end.The element struts themselves are cutin such a way that it retains somefeatures from the original laser cuttubing, which is referred to as the"wave." |
| Coring ElementActuationMechanism | Knob and lever active diametercontrol. This is achieved by therelative movement of the inner andmid shaft. The inner shaft and midshaft work together to axiallycompress or elongate the element,which in turn expands/contracts theelement to the desired treatmentdiameter. | Knob active diameter control. This isachieved by the relative movement ofthe inner and mid shaft. The innershaft and mid shaft work together toaxially compress or elongate theelement, which in turnexpands/contracts the element to thedesired treatment diameter. |
| Element Material | Nitinol laser cut hypotube | Nitinol laser cut hypotube |
| Inner CatheterMaterial | Nitinol hypotube | Nitinol hypotube |
| Middle CatheterMaterial | Nitinol Hypotube316L Stainless Steel18-8 Stainless Steel | Pebax 35D, Cool Grey 8C304V Stainless Steel316 Stainless Steel |
| Outer CatheterMaterial | Pebax 72D, Cool Grey 4CPebax 72D, Violet C316 stainless steel304V stainless steel | Pebax 63D, Cool Grey 4CPebax 63D, Violet CPebax 55D, Violet CPTFE Liner90% Platinum / 10% Iridium SplitMarker Band304V stainless steel |
| Target Vessel | Peripheral vessels 6-16 mm | Peripheral vessels 6-20 mm |
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K234034
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| Shelf-life | 6 months | 24 months |
|---|---|---|
| Guidewirecompatibility | 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
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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.
§ 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).