(256 days)
No
The document describes a mechanical thrombectomy system and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for "non-surgical removal of thrombi and emboli from blood vessels," which directly addresses and treats a medical condition (thrombi/emboli presence).
No
The ClotTriever Thrombectomy System is designed for the removal of thrombi and emboli, not for diagnosing their presence or characteristics. Its function is interventional/therapeutic, not diagnostic.
No
The device description explicitly details physical components like sheaths, catheters, dilators, syringes, and ports, indicating it is a hardware-based medical device.
Based on the provided information, the ClotTriever Thrombectomy System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes a device used for the physical removal of thrombi and emboli from blood vessels, and for the injection/aspiration of fluids. This is a direct intervention within the body.
- Device Description: The description details a system of catheters, sheaths, and accessories designed for mechanical interaction within the vascular system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are typically used in a laboratory setting or at the point of care to analyze biological samples. The ClotTriever Thrombectomy System is a therapeutic device used for a medical procedure.
N/A
Intended Use / Indications for Use
The ClotTriever Thrombectomy System 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 a blood vessel.
The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature including deep vein thrombosis (DVT).
Product codes
QEW
Device Description
The ClotTriever Thrombectomy System is a single-use, sterile medical device designed for use in the peripheral vasculature. The ClotTriever Thrombectomy System consists of the ClotTriever Sheath and the ClotTriever Catheter. The ClotTriever Sheath is made 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 included to aid insertion. Other provided accessories include the funnel loading tool and a large bore 60 cc syringe. The ClotTriever Catheter is made 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 including deep vein thrombosis (DVT)
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
Non-clinical testing was not required to support the change to the contraindications.
Clinical Testing
The CLOUT registry clinical data supporting this labeling change was originally submitted in the ClotTriever Thrombectomy System 510(k) (K193462, cleared on September 9, 2020). Peer-reviewed literature and published case reports were also submitted in support of this labeling change. The change to contraindications does not raise any new issues of safety or effectiveness.
Conclusion
The modification to replace "fibrous" and "adherent" with "predominantly fibrous" and "firmly adherent" from the list of materials contraindicated for removal using the ClotTriever Thrombectomy system aligns with the currently cleared indications for use and does not raise any new questions of safety and effectiveness. Therefore, the ClotTreiver Thrombectomy system is substantially equivalent to the predicate device
Key Metrics
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).
0
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February 6, 2023
Inari Medical, Inc. Tosan Eweka Principal Regulatory Affairs Specialist 6001 Oak Canyon, Suite 100 Irvine. California 92618
Re: K221531
Trade/Device Name: ClotTriever Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW Dated: December 22, 2022 Received: December 23, 2022
Dear Tosan Eweka:
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 W. Digitally signed by
Gregory W. Gregory W. O'connell -S O'connell -S Date: 2023.02.06
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
Device Name ClotTriever Thrombectomy System
| Indications for Use (Describe) | |
|---|---|
| -------------------------------- | -- |
The ClotTriever Thrombectomy System 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 a blood vessel.
The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature including deep vein thrombosis (DVT).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CER 801 Subpart D) | Over-The-Counter Use (21 CER 801 Subpart C) |
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3
Image /page/3/Picture/0 description: The image shows the alphanumeric string "K221531" in a bold, sans-serif font. The string appears to be a code or identifier. The characters are uniformly sized and spaced, creating a clear and legible presentation.
Image /page/3/Picture/1 description: The image shows the logo for Inari Medical. The logo consists of a circular graphic on the left and the text "INARI MEDICAL" on the right. The circular graphic is purple with orange lines inside. The text "INARI" is in large, purple letters, and the text "MEDICAL" is in smaller, gray letters below "INARI".
PAGE 1 OF 2
510(K) Summary
| Date prepared | February 3, 2023 |
|---|---|
| Name | Inari Medical—Oak Canyon |
| 6001 Oak Canyon, Suite 100 | |
| Irvine, CA 92618 | |
| Contact person | Tosan Eweka |
| Principal Regulatory Affairs Specialist | |
| 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 | ClotTriever Thrombectomy System (K212632) |
| Description | The ClotTriever Thrombectomy System is a single-use, sterile medical |
| device designed for use in the peripheral vasculature. The ClotTriever | |
| Thrombectomy System consists of the ClotTriever Sheath and the | |
| ClotTriever Catheter. The ClotTriever Sheath is made 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 included | |
| to aid insertion. Other provided accessories include the funnel loading tool | |
| and a large bore 60 cc syringe. The ClotTriever Catheter is made 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 is indicated for: |
The non-surgical removal of thrombi and emboli from blood
vessels.
2.
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 including deep vein thrombosis (DVT). |
4
Image /page/4/Picture/0 description: The image shows the logo for Inari Medical. The logo consists of a circular design on the left, with three orange curved lines inside of it. To the right of the circle is the word "INARI" in large, purple letters. Below that is the word "MEDICAL" in smaller, gray letters.
| Device modifications | Inari is updating the labeling to replace "fibrous" and "adherent' with
"predominantly fibrous” and “firmly adherent” from the list of materials
contraindicated for removal using the ClotTriever Thrombectomy system. |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of
substantial
equivalence | The ClotTriever Thrombectomy System and predicate device have the
same indications for use statements. |
| | Non-Clinical Testing
Non-clinical testing was not required to support the change to the
contraindications.
Clinical Testing
The CLOUT registry clinical data supporting this labeling change was
originally submitted in the ClotTriever Thrombectomy System 510(k)
(K193462, cleared on September 9, 2020). Peer-reviewed literature and
published case reports were also submitted in support of this labeling
change. The change to contraindications does not raise any new issues
of safety or effectiveness.
Conclusion
The modification to replace "fibrous" and "adherent" with "predominantly
fibrous" and "firmly adherent" from the list of materials contraindicated for
removal using the ClotTriever Thrombectomy system aligns with the
currently cleared indications for use and does not raise any new questions
of safety and effectiveness. Therefore, the ClotTreiver Thrombectomy
system is substantially equivalent to the predicate device |