(30 days)
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).
The ClotTriever Thrombectomy System is a single-use, sterile medical device system designed to remove thrombi and emboli from the peripheral vasculature. The ClotTriever XL Catheter is intended for vessels 10 to 28 mm in the peripheral vasculature. The ClotTriever Thrombectomy System consists of the 16Fr ClotTriever Sheath ("ClotTriever Sheath"), Protrieve Sheath and the ClotTriever XL Catheter ("Catheter"), each packaged separately.
The ClotTriever XL Catheter is a coaxial catheter assembly with a distal coring element and collection bag for retrieving thrombus. The proximal handle controls the expansion of the collection bag via the inner catheter. The outer shaft constrains the coring element and collection bag prior to deployment. Stopcocks and Luer connectors are provided for de-airing the ClotTriever XL Catheter shafts.
To aid in fluoroscopic visualization, the distal tip is radiopaque and radiopaque marker bands are located on the intermediate catheter to identify the proximal end of the coring element, and on the outer catheter to identify the distal end of ClotTriever XL outer catheter.
This document is a 510(k) summary for the Inari Medical ClotTriever XL Catheter (41-102). It describes a labeling correction to the Instructions for Use (IFU) for the device. As such, the submission focuses on verifying that the labeling changes do not alter performance or safety, rather than providing extensive de novo performance data.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Simulated Use – Clot Burden | Not explicitly stated in the provided text, but implied to demonstrate continued efficacy with IFU modifications. | Not explicitly stated, but implied to meet performance objectives for substantial equivalence. |
| Simulated Use – Tensile Testing | Not explicitly stated in the provided text, but implied to demonstrate continued structural integrity and safety with IFU modifications. | Not explicitly stated, but implied to meet performance objectives for substantial equivalence. |
| Sterilization (EtO) | Sterility Assurance Level (SAL) of 10^-6 | Achieved a SAL of 10^-6 using a validated sterilization process in accordance with ISO 11135:2014/Amd 1:2018 and AAMI TIR 28:2016. |
Explanation: The document states that "In accordance with the design failure modes and effects analysis, design validation testing was only performed on the attributes impacted by the IFU modifications." This suggests that the acceptance criteria for the "Simulated Use – Clot Burden" and "Simulated Use – Tensile Testing" would have been established based on ensuring the device continues to function as intended and safely, despite the labeling changes. However, the specific numerical or qualitative criteria for these tests are not detailed in the provided text. The conclusion of substantial equivalence implies that these criteria were met.
2. Sample Size Used for the Test Set and Data Provenance
Due to the nature of this submission being a labeling correction rather than a new device submission or significant modification, the concept of a "test set" for performance evaluation in the typical sense (e.g., a clinical trial cohort or a dataset for AI model testing) is not directly applicable.
- Sample Size for Non-Clinical Testing: Not explicitly provided for the "Simulated Use – Clot Burden" and "Simulated Use – Tensile Testing." These tests would have used an appropriate number of devices to demonstrate reproducibility and robustness, but the specific count is not mentioned.
- Data Provenance: The non-clinical testing was conducted by Inari Medical, Inc. The data is prospective for this specific submission, as it was generated to support the labeling updates. No information is provided regarding country of origin for the data, but it would typically be conducted in the country of the manufacturer (USA, in this case).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This question is not applicable to this submission. The device is a physical medical device (catheter) for thrombus removal, not an AI or diagnostic device that requires expert-established ground truth on a test set. The validation for this submission focuses on non-clinical performance and safety based on changes to the instructions for use.
4. Adjudication Method for the Test Set
This question is not applicable for the same reasons as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging devices or AI-powered clinical decision support systems where human readers interpret medical data. The ClotTriever XL Catheter is a therapeutic device, and this particular submission concerns a labeling correction, not a comparative effectiveness study of the device itself.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone performance study was not done. This question is primarily relevant for AI algorithms. The ClotTriever XL Catheter is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
For the non-clinical testing ("Simulated Use – Clot Burden" and "Simulated Use – Tensile Testing"), the "ground truth" would be established by engineering specifications, design requirements, and industry standards for device performance and safety. For example, for tensile testing, the ground truth would be breaking strength exceeding a specified threshold. For simulated clot burden, the ground truth would be successful and complete removal of simulated clots according to a predefined metric. This differs from expert consensus, pathology, or outcomes data which are relevant for diagnostic or AI-based devices.
8. The Sample Size for the Training Set
This question is not applicable. The ClotTriever XL Catheter is a physical medical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
This question is not applicable for the same reasons as point 8.
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September 27, 2024
Inari Medical, Inc. Kaitlyn Weinkauf Sr. Regulatory Affairs Specialist 6001 Oak Canyon Suite 100 Irvine, California 92618
Re: K242557
Trade/Device Name: ClotTriever XL Catheter (41-102) Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, KRA Dated: August 27, 2024 Received: August 28, 2024
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"
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(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 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.
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 Rue"). 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-advicecomprehensive-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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).
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Sincerely,
Gregory W. O'connell -S
Digitally signed by Gregory W. O'connell -S Date: 2024.09.27 08:49:33 -04'00'
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
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
ClotTriever XL Catheter (41-102)
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)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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PAGE 1 OF 2
510(K) SUMMARY
| Date prepared | September 26, 2024 |
|---|---|
| Name | Inari Medical, Inc.6001 Oak Canyon, Suite 100Irvine, CA 92618949.600.8433 |
| Contact person | Kaitlyn WeinkaufSr. Regulatory Affairs Specialist |
| Name of Device | ClotTriever XL Catheter (41-102) |
| Common name | Embolectomy Catheter |
| Regulation name | Embolectomy Catheter |
| Classification number | 21 CFR 870.5150 |
| Primary product code | QEW |
| Secondary productcode | KRA |
| Regulatory class | II |
| Predicate device | Inari Medical, ClotTriever XL Catheter (K223210) |
| Description | The ClotTriever Thrombectomy System is a single-use, sterile medical devicesystem designed to remove thrombi and emboli from the peripheral vasculature.The ClotTriever XL Catheter is intended for vessels 10 to 28 mm in the peripheralvasculature. The ClotTriever Thrombectomy System consists of the 16FrClotTriever Sheath ("ClotTriever Sheath"), Protrieve Sheath and the ClotTrieverXL Catheter ("Catheter"), each packaged separately.The ClotTriever XL Catheter is a coaxial catheter assembly with a distal coringelement and collection bag for retrieving thrombus. The proximal handle controlsthe expansion of the collection bag via the inner catheter. The outer shaft constrainsthe coring element and collection bag prior to deployment. Stopcocks and Luerconnectors are provided for de-airing the ClotTriever XL Catheter shafts.To aid in fluoroscopic visualization, the distal tip is radiopaque and radiopaquemarker bands are located on the intermediate catheter to identify the proximal endof the coring element, and on the outer catheter to identify the distal end ofClotTriever XL outer catheter. |
| 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 orfrom a blood vessel.The ClotTriever Thrombectomy System is intended for use in the peripheralvasculature including deep vein thrombosis (DVT). |
| Device Modifications | The purpose of this submission is a device labeling correction of the Instructionsfor Use (IFU) for the ClotTriever XL Catheter. The modifications included updatesto the contraindications, warnings, and procedural techniques, specifically relatingto the venous access site, retracting the catheter cranial to caudal, removal ofexcessive clot volume and the potential risk of thrombus embolization. |
| Comparison ofTechnologicalCharacteristics withthe Predicate Device | There is no change to the intended use, indications for use, technologicalcharacteristics, principles of operation, or fundamental scientific technologybetween the proposed ClotTriever XL Catheter and the predicate device. |
| Summary ofsubstantial equivalence | The proposed ClotTriever XL Catheter and the predicate device have the sameintended use, indications for use, technological characteristics, principles ofoperation, and fundamental scientific technology.Non-Clinical TestingIn accordance with the design failure modes and effects analysis, design validationtesting was only performed on the attributes impacted by the IFU modifications.The following tests were performed:Simulated Use – Clot Burden Simulated Use - Tensile Testing Clinical TestingClinical testing was not required for the determination of substantial equivalence.SterilizationThe subject device is sterilized using EtO to achieve a sterility assurance level(SAL) of 10-6 using a validated sterilization process in accordance with theprinciples of ISO 11135:2014/Amd 1:2018 and AAMI TIR 28:2016.ConclusionThe labeling modification does not change the intended use, indications for use,technological characteristics, principles of operation, or fundamental scientifictechnology between the proposed ClotTriever XL Catheter and thepredicate device. Therefore, the ClotTriever XL Catheter is deemed to besubstantially equivalent to the predicate device. |
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§ 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).