(88 days)
No
The document describes a purely mechanical, catheter-based thrombectomy system and does not mention any components or functionalities related to artificial intelligence, machine learning, or deep neural networks.
Yes
The device is used for the non-surgical removal of emboli and thrombi from blood vessels, which is a direct treatment for a medical condition.
No
The device is described as a thrombectomy system intended for the non-surgical removal of emboli and thrombi from blood vessels. Its purpose is therapeutic intervention, not diagnosis. While it targets medical conditions, it does not identify or characterize diseases.
No
The device description clearly outlines physical, catheter-based components (Sheath and Catheter) used for a mechanical thrombectomy procedure. There is no mention of software as a primary component or functionality.
No
The device is used for the mechanical removal of thrombi from blood vessels within the body, not for analyzing specimens in vitro.
N/A
Intended Use / Indications for Use
The InThrill™ Thrombectomy System is indicated for:
- The non-surgical removal of emboli and thrombi from blood vessels, including arteriovenous fistulae and arteriovenous grafts for dialysis access, and synthetic grafts.
- Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel/graft.
The InThrill™ Sheath is indicated for use as a conduit for the insertion of endovascular devices into the peripheral vasculature while minimizing blood loss associated with such insertions.
The InThrill™ Thrombectomy System is intended for use in the peripheral vasculature.
The InThrill™ Thrombectomy System is not intended for use in deep vein thrombosis (DVT) treatment.
Product codes (comma separated list FDA assigned to the subject device)
QEW, KRA, DYB
Device Description
The InThrill™ Thrombectomy System is a single-use, over-the-wire, catheter-based system for the minimally invasive treatment of thromboemboli in the peripheral vasculature, including arteriovenous fistulae and arteriovenous grafts for dialysis access, and synthetic grafts. The system comprises two main components packaged separately:
- InThrill Sheath (8 Fr)
- InThrill Thrombectomy Catheter (8 Fr)
The InThrill Sheath is placed in the target vessel, and, after its funnel is expanded, the InThrill Catheter is inserted through the sheath and advanced past the thrombus. The InThrill Catheter coring element is deployed, providing wall-to-wall contact to engage the clot, and is then retracted into the InThrill Sheath to capture the targeted thrombus. Additional clot may be removed by aspiration through the sheath with a syringe (not provided). After the procedure is complete, the InThrill Catheter and InThrill Sheath are removed from the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
blood vessels, including arteriovenous fistulae and arteriovenous grafts for dialysis access, and synthetic grafts.
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 Testing:
Verification and Validation testing were identified to support the substantial equivalence of the InThrill™ Thrombectomy System to the predicate device. These tests included:
Performance Tests
Catheter - Verification:
- Visual & Dimensional
- Guidewire Compatibility
- Hemostasis
- Conditioning
- Post-conditioning Hemostasis – Sheath
- Tensile
- Corrosion
- Torque (Characterization)
System – Validation:
- Catheter Luer Connections
- Catheter Insertion and Retraction
- Device Indicators
- Sheath Funnel Wall Apposition
- Clot Burden Removal Efficacy
- Device Deployment
- Visual Inspections
Sheath - Verification:
- Visual & Dimensional
- Fluid Leakage (Pre- and Post-Conditioning)
- Air Leakage (Pre- and Post-Conditioning)
- Vacuum Testing (Pre- and Post-Conditioning)
- Simulated Use
- Retraction with Clot Analog
- Tensile
- Torque
System – Verification:
- Radial Force (Characterization)
- Pressure (Characterization)
- Graft Abrasion
- Graft Leak
- Conditioning (In-Graft Full System and Vein-to-Graft Anastomosis)
- Comparative Thrombectomy (Characterization)
Key results: Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications.
Animal testing was not required for the determination of substantial equivalence.
Clinical testing was not required for the determination of substantial equivalence.
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.
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.
K241894, K233815, K942457, K141617
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).
FDA 510(k) Clearance Letter for InThrill™ Thrombectomy System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
May 12, 2025
Inari Medical, Inc.
Ellen Nguyen
Senior Regulatory Affairs Specialist
6001 Oak Canyon
Suite 100
Irvine, California 92618
Re: K250421
Trade/Device Name: InThrill™ Thrombectomy System
Regulation Number: 21 CFR 870.5150
Regulation Name: Embolectomy Catheter
Regulatory Class: Class II
Product Code: QEW, KRA, DYB
Dated: February 13, 2025
Received: April 16, 2025
Dear Ellen Nguyen:
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.
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K250421 - Ellen Nguyen Page 2
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).
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 QS 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 (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-reporting-combination-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 3
K250421 - Ellen Nguyen Page 3
assistance/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 ARIEL G. ASH-SHAKOOR -S
Date: 2025.05.12 11:32:06 -04'00'
For
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
Page 4
FORM FDA 3881 (8/23) Page 1 of 1
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K250421
Device Name
InThrill™ Thrombectomy System
Indications for Use (Describe)
The InThrill™ Thrombectomy System is indicated for:
- The non-surgical removal of emboli and thrombi from blood vessels, including arteriovenous fistulae and arteriovenous grafts for dialysis access, and synthetic grafts.
- Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel/graft.
The InThrill™ Sheath is indicated for use as a conduit for the insertion of endovascular devices into the peripheral vasculature while minimizing blood loss associated with such insertions.
The InThrill™ Thrombectomy System is intended for use in the peripheral vasculature.
The InThrill™ Thrombectomy System is not intended for use in deep vein thrombosis (DVT) treatment.
Type of Use (Select one or both, as applicable)
[X] Prescription Use (Part 21 CFR 801 Subpart D) [ ] Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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Page 5
K250421 PAGE 1 OF 4
510(K) SUMMARY
Date prepared May 5, 2025
Name Inari Medical, Inc.
6001 Oak Canyon, Suite 100
Irvine, CA 92618
703.347.5004
Contact person Ellen Nguyen
Senior Regulatory Affairs Specialist
Name of Device InThrill™ Thrombectomy System
Product code(s) QEW; KRA; DYB
Regulation 21 CFR 870.5150 Embolectomy catheter
Regulatory class II
Predicate device(s) Inari Medical, InThrill™ Thrombectomy System (K223613)
This device has not been subject to a design-related recall.
Reference device(s) Inari Medical, Artix MT/Artix Thin-Walled Sheath (K241894)
Inari Medical, ClotTriever Thrombectomy System (K233815)
Intramed Laboratories, Inc., Graft Thrombectomy Instruments (K942457)
Rex Medical, Cleaner Rotational Thrombectomy System (K141617)
Description The InThrill™ Thrombectomy System is a single-use, over-the-wire, catheter-based system for the minimally invasive treatment of thromboemboli in the peripheral vasculature, including arteriovenous fistulae and arteriovenous grafts for dialysis access, and synthetic grafts. The system comprises two main components packaged separately:
- InThrill Sheath (8 Fr)
- InThrill Thrombectomy Catheter (8 Fr)
The InThrill Sheath is placed in the target vessel, and, after its funnel is expanded, the InThrill Catheter is inserted through the sheath and advanced past the thrombus. The InThrill Catheter coring element is deployed, providing wall-to-wall contact to engage the clot, and is then retracted into the InThrill Sheath to capture the targeted thrombus. Additional clot may be removed by aspiration through the sheath with a syringe (not provided). After the procedure is complete, the InThrill Catheter and InThrill Sheath are removed from the patient.
Indications for Use The InThrill™ Thrombectomy System is indicated for:
- The non-surgical removal of emboli and thrombi from blood vessels, including arteriovenous fistulae and arteriovenous grafts for dialysis access, and synthetic grafts.
- Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel/graft.
The InThrill™ Sheath is indicated for use as a conduit for the insertion of
Page 6
K250421 PAGE 2 OF 4
endovascular devices into the peripheral vasculature while minimizing blood loss associated with such insertions.
The InThrill™ Thrombectomy System is intended for use in the peripheral vasculature.
The InThrill™ Thrombectomy System is not intended for use in deep vein thrombosis (DVT) treatment.
Summary of substantial equivalence A tabular comparison of the predicate and subject devices is provided below:
| Subject Device | Primary Predicate | |
|---|---|---|
| InThrill™ Thrombectomy System | InThrill™ Thrombectomy System | |
| K Number | K250421 | K223613 |
| Manufacturer | Inari Medical, Inc. | Inari Medical, Inc. |
| Product Code | QEW, KRA, DYB | QEW, KRA |
| Indications for Use | The InThrill™ Thrombectomy System is indicated for: | |
| • The non-surgical removal of emboli and thrombi from blood vessels, including arteriovenous fistulae and arteriovenous grafts for dialysis access, and synthetic grafts. | ||
| • Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel/graft. |
The InThrill™ Sheath is indicated for use as a conduit for the insertion of endovascular devices into the peripheral vasculature while minimizing blood loss associated with such insertions.
The InThrill™ Thrombectomy System is intended for use in the peripheral vasculature.
The InThrill™ Thrombectomy System is not intended for use in deep vein thrombosis (DVT) treatment. | The InThrill™ Thrombectomy System is indicated for:
• The non-surgical removal of emboli and thrombi from blood vessels, including arteriovenous fistulae and arteriovenous grafts for dialysis access, and synthetic grafts.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel/graft.
The InThrill™ Thrombectomy System is intended for use in the peripheral vasculature.
The InThrill™ Thrombectomy System is not intended for use in deep vein thrombosis (DVT) treatment. |
| Sterility | Same | SAL 10^-6, EO |
| Shelf-life | 6 months | 2 years |
| Guidewire compatibility | Same | 0.035" |
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K250421 PAGE 3 OF 4
| Device dimensions | Same except for a longer sheath tip taper and changes to coring element (longer length, smaller diameter, and change to geometry) | Appropriately sized for the target vessel treatment range |
|---|---|---|
| Device and packaging materials | Same with decreased Pebax durometer at sheath shaft tip, increased Pebax durometer at catheter shaft tip, and change from two coaxial braided shaft to a single, thicker shaft | Biocompatible, commonly used materials for medical devices |
| Accessories provided | Dilator, pre-dilator, element support tool | Dilator, pre-dilator |
Summary of substantial equivalence
Biocompatibility
The following biocompatibility tests were completed for the subject device:
- Cytotoxicity
- Intracutaneous Reactivity
- Material-Mediated Pyrogenicity
- Hemocompatibility (Hemolysis, Complement Activation)
- Sensitization
- Acute Systemic Toxicity
- Thromboresistance (Platelet and Leukocyte Count, Partial Thromboplastin Time, and Anticoagulated Venous Implant Study)
The passing results demonstrate that the subject device and accessories meet biological safety requirements per ISO 10993-1.
Sterilization
The subject device, including its accessories, is sterilized using EtO to achieve a sterility assurance level (SAL) of 10^-6 using a validated sterilization process in accordance with the principles of ISO 11135:2014/Amd 1:2018 and AAMI TIR 28:2016.
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 InThrill™ Thrombectomy System to the predicate device. These tests included:
Performance Tests
Catheter - Verification:
- Visual & Dimensional
- Guidewire Compatibility
- Hemostasis
- Conditioning
- Post-conditioning Hemostasis – Sheath
- Tensile
- Corrosion
- Torque (Characterization)
Page 8
K250421 PAGE 4 OF 4
System – Validation:
- Catheter Luer Connections
- Catheter Insertion and Retraction
- Device Indicators
- Sheath Funnel Wall Apposition
- Clot Burden Removal Efficacy
- Device Deployment
- Visual Inspections
Sheath - Verification:
- Visual & Dimensional
- Fluid Leakage (Pre- and Post-Conditioning)
- Air Leakage (Pre- and Post-Conditioning)
- Vacuum Testing (Pre- and Post-Conditioning)
- Simulated Use
- Retraction with Clot Analog
- Tensile
- Torque
System – Verification:
- Radial Force (Characterization)
- Pressure (Characterization)
- Graft Abrasion
- Graft Leak
- Conditioning (In-Graft Full System and Vein-to-Graft Anastomosis)
- Comparative Thrombectomy (Characterization)
Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications.
Animal testing was not required for the determination of substantial equivalence.
Clinical testing was not required for the determination of substantial equivalence.
Conclusion
The InThrill™ Thrombectomy System has the same intended use and principles of operation as the predicate. Non-clinical 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 InThrill™ Thrombectomy System's substantial equivalence to the predicate device.