(24 days)
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.
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.
This document describes the ClotTriever Thrombectomy System, a medical device for removing thrombi and emboli from blood vessels. However, the provided text does not contain information about a study proving the device meets acceptance criteria in the context of an AI/algorithm performance study.
The document is a 510(k) premarket notification summary for an updated version of the ClotTriever Thrombectomy System, comparing it to a previously cleared predicate device. The "acceptance criteria" discussed are related to non-clinical engineering and material tests to demonstrate that the modified physical device is substantially equivalent to the predicate device, not performance benchmarks for an AI or algorithm.
Therefore, I cannot fulfill the request to describe the acceptance criteria and study proving the device meets those criteria, as well as the related details (sample size, experts, adjudication, MRMC, standalone, ground truth, training set details) because this information is not present in the provided text.
The "Non-Clinical Testing" section explicitly states: "Clinical testing was not required for the determination of substantial equivalence." This further confirms that no human-centric performance study (like an AI study would entail) was conducted or presented in this 510(k) submission.
Summary of what can be extracted regarding "acceptance criteria" and "study" for this physical device:
- Acceptance Criteria and Reported Device Performance (Table): Not directly available in a table format for performance in the AI sense. The text mentions "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications and intended use." The types of non-clinical tests that presumably had acceptance criteria are listed:
- Visual & Dimensional Inspections
- Guidewire Compatibility
- Tensile testing
- Test Conical Fittings with 6% Luer taper
- (No specific performance metrics are given, only that criteria were met).
- Sample size for the test set and data provenance: N/A for an AI/algorithm study. The "test set" here refers to the physical devices manufactured for non-clinical testing, not a dataset of patient images.
- Number of experts used to establish ground truth & qualifications: N/A. Ground truth for these physical tests would be engineering specifications and measurements.
- Adjudication method: N/A.
- MRMC comparative effectiveness study: No. "Clinical testing was not required."
- Standalone (algorithm only without human-in-the-loop performance): No, this is for a physical medical device.
- Type of ground truth used: For the physical device, ground truth would be engineering specifications, material standards, and physical measurements.
- Sample size for the training set: N/A.
- How the ground truth for the training set was established: N/A.
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September 20, 2019
Inari Medical, Inc. Mr. Eben Gordon Vice President, Regulatory Affairs & Quality Assurance 9272 Jeronimo Rd., Suite 124 Irvine, California 92618
Re: K192332
Trade/Device Name: ClotTriever Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW Dated: August 24, 2019 Received: August 27, 2019
Dear Mr. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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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 (OS) 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.
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
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Indications for Use
510(k) Number (if known) K192332
Device Name ClotTriever Thrombectomy System
Indications for Use (Describe) 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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510(K) SUMMARY
| Date prepared | August 24, 2019 |
|---|---|
| Name | Inari Medical, Inc.9272 Jeronimo Road, Suite 124Irvine, CA 92618949.600.8433 x114 |
| Contact person | Eben GordonVice 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) |
| Description | The ClotTriever Thrombectomy System is a single-use, sterile medicaldevice designed for use in the peripheral vasculature. The ClotTrieverThrombectomy System is comprised of the ClotTriever Sheath and theClotTriever Catheter. The ClotTriever Sheath consists of a reinforcedpolymeric sheath equipped with a self-expanding distal mesh funnel, aflush/aspiration port, and a proximal hemostatic valve. A dilator is providedto aid insertion. Other provided accessories include the funnel loading tooland a Large Bore 60 cc syringe. The ClotTriever Catheter consists ofreinforced polymeric coaxial shafts terminating in an expandable coringelement and thrombus collection bag. Two ports terminating in stopcocksare provided for de-airing the catheter shafts. To aid in fluoroscopicvisualization, the Sheath dilator and ClotTriever Catheter distal tips areradiopaque. |
| Indications for Use | The ClotTriever Thrombectomy System is indicated for:• The non-surgical removal of soft thrombi and emboli from bloodvessels.• Injection, infusion, and/or aspiration of contrast media and otherfluids into or from a blood vessel.The ClotTriever Thrombectomy System is intended for use in the peripheralvasculature. |
| Device modifications | The changes to the ClotTriever Thrombectomy System, limited to theClotTriever Catheter, are: |
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- New proximal Luer connector for flushing the inner catheter lumen ● and guidewire backloading
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:
- . Visual & Dimensional Inspections
- Guidewire Compatibility ●
- Tensile testing
- Test Conical Fittings with 6% Luer taper .
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.
Summary of substantial equivalence
§ 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).