(30 days)
No
The device description and intended use focus on mechanical components and procedures, with no mention of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is indicated for "non-surgical removal of soft thrombi and emboli from blood vessels," which is a therapeutic intervention aimed at treating medical conditions.
No
Explanation: The ClotTriever Thrombectomy System is designed for the non-surgical removal of thrombi and emboli, and for injection/aspiration, which are therapeutic and procedural functions, not diagnostic ones. While it mentions fluoroscopic visualization for aid, this is for guidance during the procedure, not for diagnosing a condition.
No
The device description explicitly details physical components like a sheath, catheter, dilator, syringe, and other accessories, 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 clearly describes a device for the non-surgical removal of thrombi and emboli from blood vessels and for injection, infusion, and/or aspiration of fluids into or from a blood vessel. These are procedures performed in vivo (within the living body).
- Device Description: The description details a system of sheaths, catheters, and accessories designed for physical intervention within blood vessels.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens outside of the body (in vitro) to provide diagnostic information. IVDs are typically used to test blood, urine, tissue, or other samples in a laboratory setting.
The device is a medical device used for therapeutic and procedural purposes within the peripheral vasculature, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The ClotTriever Thrombectomy System consists of the ClotTriever Catheter and ClotTriever Sheath. The ClotTriever Thrombectomy System is indicated for:
- The non-surgical removal of soft thrombi and emboli from blood vessels.
- Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature.
Product codes
OEW
Device Description
The ClotTriever Thrombectomy System is a single-use, sterile medical device designed for use in the peripheral vasculature. The ClotTriever Thrombectomy System is comprised of the ClotTriever Sheath and the ClotTriever Catheter. The ClotTriever Sheath consists of a reinforced polymeric sheath equipped with a self-expanding distal mesh funnel, a flush/aspiration port, and a proximal hemostatic valve. A dilator is provided to aid insertion. Other provided accessories include the funnel loading tool and a Large Bore 60 cc syringe. The ClotTriever Catheter consists of reinforced polymeric coaxial shafts terminating in an expandable coring element and thrombus collection bag. Two ports terminating in stopcocks are provided for de-airing the catheter shafts. To aid in fluoroscopic visualization, the Sheath dilator and ClotTriever Catheter distal tips are radiopaque.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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 modified ClotTriever Thrombectomy System to the predicate device. This testing demonstrated compliance with relevant product specifications. These tests were:
- Pouch Seal Inspection
- Dye Penetration Inspection
- Visual & Dimensional Inspections ClotTriever Sheath
- Visual & Dimensional Inspections ClotTriever Dilator
- Visual & Dimensional Inspections Loading Tool
- Guidewire Compatibility Verification, ClotTriever Dilator
- Deployment Force ClotTriever Sheath from Dilator
- Retraction Force Dilator Thru ClotTriever Sheath
- Insertion Verification ClotTriever Delivery Catheter thru Sheath
- Retraction of the ClotTriever Catheter Thru ClotTriever Sheath
- Kink Resistance/Radius Verification ClotTriever Sheath & Dilator
- Leakage Verification, ClotTriever Sheath
- Leakage Verification, ClotTriever Dilator
- Fluid Test Thru ClotTriever Sheath/Dilator
- ClotTriever Dilator Retraction in Clot Analog
- Simulated Use, Track and Rotation ClotTriever Sheath
- Simulated Use, Track and Tensile ClotTriever Dilator
- Simulated Use, Track and Tensile ClotTriever Sheath
- Insertion and Placement Resistance
- Corrosion Resistance.
Clinical testing was not required for the determination of substantial equivalence.
Conclusion
Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications and intended use. Based upon the same intended use and principle of operation, technology, and nonclinical testing it is concluded that the modified ClotTriever Thrombectomy System is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Inari Medical's ClotTriever Thrombectomy System (K182531)
Reference Device(s)
Inari Medical's ClotTriever Thrombectomy System (K163549), Inari Medical's ClotTriever Thrombectomy System (K173470), Inari Medical's FlowTriever Retrieval/Aspiration System (K182233)
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 logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo 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.
August 29, 2019
Inari Medical Eben Gordon Vice President, RA/QA 9272 Jeronimo Rd., Suite 124 Irvine, California 92618
Re: K192036
Trade/Device Name: ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: OEW Dated: July 27, 2019 Received: July 30, 2019
Dear Eben Gordon:
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 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 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) K192036
Device Name ClotTriever Thrombectomy System
Indications for Use (Describe)
The ClotTriever Thrombectomy System consists of the ClotTriever Sheath. The ClotTriever Thrombectomy System is indicated for:
- · The non-surgical removal of soft thrombi and emboli from blood vessels.
- · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature.
| 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)
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3
510(K) SUMMARY
| Date prepared | July 29, 2019 | ||
|---|---|---|---|
| Name | Inari Medical, Inc. | ||
| 9272 Jeronimo Road, Suite 124 | |||
| Irvine, CA 92618 | |||
| 949.600.8433 x114 | |||
| Contact person | Eben Gordon | ||
| Vice President, Regulatory Affairs & Quality Assurance | |||
| Trade name | ClotTriever Thrombectomy System | ||
| Common name | Embolectomy catheter | ||
| Regulation name | Embolectomy catheter | ||
| Classification number | 21 CFR 870.5150 | ||
| Product code | QEW | ||
| Regulatory class | II | ||
| Predicate device | Inari Medical's ClotTriever Thrombectomy System (K182531) | ||
| Reference devices | Inari Medical's ClotTriever Thrombectomy System (K163549) | ||
| Inari Medical's ClotTriever Thrombectomy System (K173470) | |||
| Inari Medical's FlowTriever Retrieval/Aspiration System (K182233) | |||
| Description | The ClotTriever Thrombectomy System is a single-use, sterile medical | ||
| device designed for use in the peripheral vasculature. The ClotTriever | |||
| Thrombectomy System is comprised of the ClotTriever Sheath and the | |||
| ClotTriever Catheter. The ClotTriever Sheath consists of a reinforced | |||
| polymeric sheath equipped with a self-expanding distal mesh funnel, a | |||
| flush/aspiration port, and a proximal hemostatic valve. A dilator is provided | |||
| to aid insertion. Other provided accessories include the funnel loading tool | |||
| and a Large Bore 60 cc syringe. The ClotTriever Catheter consists of | |||
| reinforced polymeric coaxial shafts terminating in an expandable coring | |||
| element and thrombus collection bag. Two ports terminating in stopcocks | |||
| are provided for de-airing the catheter shafts. To aid in fluoroscopic | |||
| visualization, the Sheath dilator and ClotTriever Catheter distal tips are | |||
| radiopaque. | |||
| Indications for Use | The ClotTriever Thrombectomy System consists of the ClotTriever Catheter | ||
| and ClotTriever Sheath. The ClotTriever Thrombectomy System is indicated | |||
| for: | |||
| • The non-surgical removal of soft thrombi and emboli from blood vessels. | |||
| • Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. |
4
The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature.
The changes to the ClotTriever Thrombectomy System are limited to the Device modifications ClotTriever Sheath and include the following changes:
- ClotTriever Sheath ID increased from 0.182" to 0.215"
- ClotTriever Sheath OD increased from 0.210" to 0.248" ●
- Dilator OD increased from 0.178" to 0.206" ●
- ClotTriever Sheath distal mesh funnel length decreased from 1.60" to ● 0.90" and nitinol wire diameter increased 0.0005"
- ClotTriever Sheath proximal shaft changed durometer from Pebax 72D to Pebax 63D
- ClotTriever Sheath hub changed from Pebax 72D to polycarbonate .
There is no change of intended use or fundamental scientific technology between the modified and predicate devices.
Non-Clinical Testing
Verification and validation testing were identified to support the substantial equivalence of the modified ClotTriever Thrombectomy System to the predicate device. This testing demonstrated compliance with relevant product specifications. These tests were:
- Pouch Seal Inspection ●
- Dye Penetration Inspection
- Visual & Dimensional Inspections ClotTriever Sheath ●
- Visual & Dimensional Inspections ClotTriever Dilator ●
- Visual & Dimensional Inspections Loading Tool ●
- Guidewire Compatibility Verification, ClotTriever Dilator ●
- Deployment Force ClotTriever Sheath from Dilator ●
- Retraction Force Dilator Thru ClotTriever Sheath ●
- Insertion Verification ClotTriever Delivery Catheter thru Sheath ●
- Retraction of the ClotTriever Catheter Thru ClotTriever Sheath
- Kink Resistance/Radius Verification ClotTriever Sheath & Dilator ●
- Leakage Verification, ClotTriever Sheath ●
- Leakage Verification, ClotTriever Dilator ●
- Fluid Test Thru ClotTriever Sheath/Dilator ●
- ClotTriever Dilator Retraction in Clot Analog
- Simulated Use, Track and Rotation ClotTriever Sheath ●
- Simulated Use, Track and Tensile ClotTriever Dilator ●
- Simulated Use, Track and Tensile ClotTriever Sheath ●
- Insertion and Placement Resistance ●
- Corrosion Resistance .
Clinical testing was not required for the determination of substantial equivalence.
Summarv of substantial equivalence
5
Conclusion
Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications and intended use. Based upon the same intended use and principle of operation, technology, and nonclinical testing it is concluded that the modified ClotTriever Thrombectomy System is substantially equivalent to the predicate device.