(26 days)
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.
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 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 60 cc syringe. The ClotTriever Catheter consists of polymeric coaxial shafts terminating in an expandable coring element and thrombus collection bag. At the proximal end of the catheter is a handle used to enable tensioning of the coring element. Two ports terminating in stopcocks are provided for de-airing the catheter shafts. To aid in fluoroscopic visualization, the dilator and ClotTriever Catheter distal tips are radiopaque.
The provided document is a 510(k) summary for the ClotTriever Thrombectomy System, which is a medical device for removing thrombi and emboli. It describes non-clinical testing performed to demonstrate substantial equivalence to a predicate device, but it explicitly states that clinical testing was not required. Therefore, the document does not contain information about a study proving the device meets acceptance criteria related to clinical performance or human reader effectiveness.
However, based on the non-clinical testing section, I can provide information about the acceptance criteria and performance as described for those tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Visual & Dimensional Inspections | Not explicitly stated, implied to be conformity to design specifications. | All acceptance criteria were met. |
| Retraction Force of Handle | Not explicitly stated, implied to be conformity to design specifications. | All acceptance criteria were met. |
| Syringe Leak Testing | Not explicitly stated, implied to be conformity to design specifications. | All acceptance criteria were met. |
| Syringe Vacuum Testing | Not explicitly stated, implied to be conformity to design specifications. | All acceptance criteria were met. |
| Syringe Tensile Testing | Not explicitly stated, implied to be conformity to design specifications. | All acceptance criteria were met. |
| Clot burden Removal Performance Test | Not explicitly stated, implied to be conformity to design specifications. | All acceptance criteria were met. |
| Simulated Use, Tensile Test | Not explicitly stated, implied to be conformity to design specifications. | All acceptance criteria were met. |
2. Sample size used for the test set and the data provenance:
For the non-clinical tests listed, the sample sizes are not explicitly provided in this 510(k) summary. The data provenance is generally "non-clinical testing" conducted by the manufacturer, Inari Medical, Inc. The document does not specify country of origin for the data (as it's laboratory testing, this is typically internal to the manufacturer). It is, by definition, a prospective testing of the device prototypes/units.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. These are non-clinical engineering and performance tests, not clinical evaluations requiring expert interpretation of medical images or patient outcomes.
4. Adjudication method for the test set:
Not applicable for these non-clinical tests.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No. This device is a thrombectomy system (a mechanical device), not an AI-powered diagnostic tool. Clinical testing was also not performed or required for this particular submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No. This is a physical medical device, not a standalone algorithm.
7. The type of ground truth used:
For the non-clinical tests, the "ground truth" would be established engineering specifications, performance standards, and physical measurements/observations during the tests. For example, for "Syringe Leak Testing," the ground truth would be the absence of leaks under specified conditions.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
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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 and 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.
October 10, 2018
Inari Medical Eben Gordon Vice President, RA/QA 9272 Jeronimo Road Suite 124 Irvine, California 92618
Re: K182531
Trade/Device Name: ClotTriever Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: DXE Dated: September 13, 2018 Received: September 14, 2018
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
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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 and Part 809); 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 2018.10.10 19:33:20 -04'00" For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182531
Device Name ClotTriever Thrombectomy System
Indications for Use (Describe)
The ClotTriever Thrombectomy System consists of the ClotTriever Catheter and 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 | September 13, 2018 |
|---|---|
| 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 |
| Classificationnumber | 21 CFR 870.5150 |
| Product code | DXE |
| Regulatory class | II |
| Predicate device | Inari Medical's ClotTriever Thrombectomy System (K180329) |
| Referencedevices | Inari Medical's ClotTriever Thrombectomy System (K173470)Inari Medical's ClotTriever Thrombectomy System (K163549) |
| Description | The ClotTriever Thrombectomy System is a single-use, sterile medical devicedesigned for use in the peripheral vasculature. The ClotTriever ThrombectomySystem is comprised of the ClotTriever Sheath and the ClotTriever Catheter. TheClotTriever Sheath consists of a polymeric sheath equipped with a self-expandingdistal mesh funnel, a flush/aspiration port, and a proximal hemostatic valve. Adilator is provided to aid insertion. Other provided accessories include the funnelloading tool and a 60 cc syringe. The ClotTriever Catheter consists of polymericcoaxial shafts terminating in an expandable coring element and thrombuscollection bag. At the proximal end of the catheter is a handle used to enabletensioning of the coring element. Two ports terminating in stopcocks areprovided for de-airing the catheter shafts. To aid in fluoroscopic visualization, thedilator and ClotTriever Catheter distal tips are radiopaque. |
| Indications forUse | The ClotTriever Thrombectomy System consists of the ClotTriever Catheter andClotTriever 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 peripheralvasculature. |
| Devicemodifications | The changes to the ClotTriever Thrombectomy System are: |
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Page 2 of 2
- . Decrease in the length of the ClotTriever Catheter's thrombus collection bag from 34 cm to 19 cm
- Decrease in the deployed length from 125 cm to 105 cm ●
- Replacement of the off-the-shelf 60 cc VacLok Syringe and Clot Reservoir with a large bore 60 cc VacLok Syringe.
Summary of There is no change of intended use or fundamental scientific technology between substantial the modified and predicate devices. equivalence
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 modified ClotTriever Thrombectomy System to the predicate device. This testing demonstrated compliance with relevant product specifications. These tests included:
- Visual & Dimensional Inspections
- Retraction Force of Handle
- Syringe Leak Testing ●
- Syringe Vacuum Testing
- Syringe Tensile Testing ●
- Clot burden Removal Performance Test ●
- Simulated Use, Tensile Test ●
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.
§ 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).