(65 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 designed for use in the peripheral vasculature. The ClotTriever Thrombectomy System consists of the ClotTriever Sheath and the ClotTriever Catheter. The ClotTriever Sheath comprises a reinforced polymeric sheath equipped with a self-expanding distal mesh funnel, a flush/aspiration port, and a proximal hemostatic valve. The ClotTriever Catheter is comprised of reinforced polymeric coaxial shafts terminating in an expandable coring element and thrombus collection bag. Three 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. Other provided accessories include a pre-dilator, the funnel loading tool and a Large Bore 60 cc syringe
The provided document is a 510(k) premarket notification for the ClotTriever Thrombectomy System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical performance data. It does not typically involve extensive clinical studies with human subjects in the same way a PMA (Premarket Approval) submission would, especially for an AI/ML-driven device.
Therefore, many of the requested elements for describing acceptance criteria and a study proving a device meets acceptance criteria in an AI/ML context (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance) are not applicable to this specific document. This document focuses on the mechanical and functional performance of a medical device (a thrombectomy system with a pre-dilator) through non-clinical testing.
Here's the information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications." However, it does not explicitly list the quantitative acceptance criteria for each test. It only lists the types of non-clinical testing performed.
| Test Type | Acceptance Criteria (Not explicitly quantified in document) | Reported Device Performance |
|---|---|---|
| Visual and Dimensional Inspection | Device meets specified visual and dimensional requirements. | All acceptance criteria were met. |
| Guidewire Compatibility | Device is compatible with specified guidewire. | All acceptance criteria were met. |
| Leak Testing | Device does not leak beyond acceptable limits. | All acceptance criteria were met. |
| Simulated Use | Device performs as intended during simulated use. | All acceptance criteria were met. |
| Insertion/Kink Radius Testing | Device resists kinking and can be inserted as intended. | All acceptance criteria were met. |
| Tensile Testing | Device meets specified tensile strength requirements. | All acceptance criteria were met. |
| In Vivo Functional Testing/Radiopacity Verification | Device functions as intended in vivo (animal or cadaver model implied) and is radiopaque as specified. | All acceptance criteria were met. |
| Pouch Seal Visual Inspection and Dye Penetration | Pouch seals are intact and prevent dye penetration. | All acceptance criteria were met (leveraged from K163549). |
| Pouch, Peel, Seal Strength | Pouch seals meet specified strength requirements for opening. | All acceptance criteria were met (leveraged from K163549). |
| Sterilization Validation | Device is effectively sterilized. | All acceptance criteria were met (leveraged from K163549). |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of units tested) for each type of non-clinical test. The data provenance is internal testing performed by Inari Medical, Inc. The nature of the testing (bench, in-vitro, and potentially in vivo animal/cadaver for functional testing) indicates it's likely prospective data collection for the purpose of this submission. The origin of the data is the manufacturer's testing facility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a medical device submission based on non-clinical engineering and performance testing, not an AI/ML algorithm requiring expert review for ground truth establishment.
4. Adjudication method for the test set
Not applicable. This is not an AI/ML study requiring expert adjudication of outputs. The tests are typically conducted according to standardized protocols with defined acceptance criteria.
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
Not applicable. This device is a mechanical thrombectomy system, not an AI-assisted diagnostic or therapeutic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm. The testing described is for the mechanical and functional performance of the device itself.
7. The type of ground truth used
For the non-clinical tests, the "ground truth" is defined by the product specifications and performance standards for the device, and established engineering principles for evaluating medical device safety and effectiveness. For example:
- Visual and Dimensional Inspection: Comparison against engineering drawings and design specifications.
- Leak Testing: Absence of fluid egress under specified pressure.
- Tensile Testing: Measurement against predefined force resistance requirements.
- In Vivo Functional Testing: Successful and safe operation in a relevant biological model (e.g., animal or cadaver model, though the document does not specify which was used or the exact endpoints, only that the test was conducted).
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. This is not an AI/ML device.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 12, 2021
Inari Medical, Inc. Larry Boucher Regulatory Affairs Manager 9 Parker. Suite 100 Irvine, California 92618
Re: K210689
Trade/Device Name: ClotTriever Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW Dated: March 15, 2021 Received: March 16, 2021
Dear Larry Boucher:
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
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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 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).
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
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Indications for Use
510(k) Number (if known) K210689
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).
|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 | March 15, 2021 |
|---|---|
| Name | Inari Medical, Inc.9 Parker, Suite 100Irvine, CA 92618949.600.8433 x114 |
| Contact person | Larry BoucherRegulatory Affairs Manager |
| 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 (K210190) |
| Reference Device | Cook Incorporated Dilator Sets (K183036) |
| Description | The ClotTriever Thrombectomy System is a single-use, sterile medical devicedesigned for use in the peripheral vasculature. The ClotTrieverThrombectomy System consists of the ClotTriever Sheath and theClotTriever Catheter. The ClotTriever Sheath comprises a reinforcedpolymeric sheath equipped with a self-expanding distal mesh funnel, aflush/aspiration port, and a proximal hemostatic valve. The ClotTrieverCatheter is comprised of reinforced polymeric coaxial shafts terminating inan expandable coring element and thrombus collection bag. Three portsterminating in stopcocks are provided for de-airing the catheter shafts. Toaid in fluoroscopic visualization, the Sheath dilator and ClotTriever Catheterdistal tips are radiopaque. Other provided accessories include a pre-dilator,the funnel loading tool and a Large Bore 60 cc syringe |
| 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 peripheralvasculature including deep vein thrombosis (DVT). |
| Device modification | A pre-dilator that can be inserted into and dilate the target vessel prior tothe insertion of the ClotTriever Sheath will be provided with the ClotTriever system:A 16 Fr pre-dilator will be included with the 13 Fr ClotTriever Sheath A 19 Fr pre-dilator will be included with the 16 Fr ClotTriever Sheath The purpose for providing the pre-dilator is to assure its availability for the ClotTriever thrombectomy procedure. |
| Summary ofsubstantialequivalence | The ClotTriever pre-dilator and the predicate device have the same intended use: To be used for dilating puncture sites or catheter tracts for percutaneous placement of devices.The addition of the pre-dilator does not change the intended use of the ClotTriever Thrombectomy System: removal of thrombus and emboli from and infusion of fluids into the peripheral vasculature. |
| Non-Clinical TestingIn accordance with the Design Failure Modes and Effects Analysis, verification and validation testing were identified to support the substantial equivalence of the pre-dilator. This testing demonstrated compliance with relevant product specifications. These tests included: Visual and Dimensional Inspection Guidewire Compatibility Leak Testing Simulated Use Insertion/Kink Radius Testing Tensile Testing In Vivo Functional Testing/Radiopacity Verification The following testing was leveraged from K163549: Pouch Seal Visual Inspection and Dye Penetration Pouch, Peel, Seal Strength Sterilization Validation Clinical testing was not required for the determination of substantial equivalence.Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications. | |
| ConclusionThe proposed device modification to the ClotTriever Thrombectomy System does not change its intended use nor does it change the principles of operation. With consideration of the results of the testing, it can be concluded that the proposed pre-dilator is substantially equivalent to the predicate device. |
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| Device | ClotTriever Thrombectomy SystemProposed (TBD) | ClotTriever Thrombectomy SystemPredicate (K210190) | Cook Inc. Dilator SetsReference (K183036) |
|---|---|---|---|
| Manufacturer | Inari Medical | Inari Medical | Cook Inc. |
| Product code | QEW, DRE | QEW | DRE |
| Intended use | Removal of thrombus and emboli from, and infusion offluids into, the peripheral vasculature. | Removal of thrombus and emboli from, and infusion offluids into, the peripheral vasculature. | Intended to be used for dilating puncture sites orcatheter tracts for percutaneous placement of devicesfor vascular and non-vascular applications such as inthe venous, arterial, biliary and renal systems. |
| Indications for use | The ClotTriever Thrombectomy System is indicated for:• The non-surgical removal of thrombi and emboli fromblood vessels.• Injection, infusion, and/or aspiration of contrast mediaand other fluids into or from a blood vessel.The ClotTriever Thrombectomy System is intended for use inthe peripheral vasculature including deep vein thrombosis(DVT). | The ClotTriever Thrombectomy System is indicated for:• The non-surgical removal of thrombi and emboli fromblood vessels.• Injection, infusion, and/or aspiration of contrast mediaand other fluids into or from a blood vessel.The ClotTriever Thrombectomy System is intended for use inthe peripheral vasculature including deep vein thrombosis(DVT). | Intended to be used for dilating puncture sites orcatheter tracts for percutaneous placement of devicesfor vascular and non-vascular applications such as inthe venous, arterial, biliary and renal systems. |
| Device Description | The ClotTriever Thrombectomy System consists of theClotTriever Sheath and the ClotTriever Catheter. TheClotTriever Sheath comprises a reinforced polymeric sheathequipped with a self-expanding distal mesh funnel, aflush/aspiration port, and a proximal hemostatic valve. TheClotTriever Catheter is comprised of reinforced polymericcoaxial shafts terminating in an expandable coring elementand thrombus collection bag. Other provided accessoriesinclude a pre-dilator, the funnel loading tool and a LargeBore 60 cc syringe | The ClotTriever Thrombectomy System consists of theClotTriever Sheath and the ClotTriever Catheter. TheClotTriever Sheath comprises a reinforced polymeric sheathequipped with a self-expanding distal mesh funnel, aflush/aspiration port, and a proximal hemostatic valve. TheClotTriever Catheter is comprised of reinforced polymericcoaxial shafts terminating in an expandable coring elementand thrombus collection bag. Other provided accessoriesinclude the funnel loading tool and a Large Bore 60 ccsyringe | Cook Dilator Sets are used percutaneously to dilatepuncture sites or catheter tracts, thereby facilitatingthe placement of other therapeutic or diagnosticdevices into a natural body space (e.g., the peritonealcavity, an artery or vein) for various vascular or non-vascular clinical applications. The dilator component ofthe Dilator Sets is available in diameters ranging from3.0 to 26.0 French and in lengths ranging from 6 to 65cm. The broad range of dilator sizes accommodates thevariation in the size of the K183036 devices that couldbe inserted through the initial access site. |
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| Device | ClotTriever Thrombectomy SystemProposed (TBD) | ClotTriever Thrombectomy SystemPredicate (K210190) | Cook Inc. Dilator SetsReference (K183036) |
|---|---|---|---|
| Principles of operation | The ClotTriever Catheter is advanced into the vessel andbeyond the clot. The self-expanding braided nitinol wire netis deployed. The expanded net cores, separates, and entrapsthrombus from the vessel as it is being drawn to the funnelopening of the ClotTriever Sheath. The net is collapsed andpulled into and through the ClotTriever Sheath with theentrapped clot. A 60 cc syringe is provided for the aspirationof clot in the sheath and the infusion of contrast media andother fluids. | The ClotTriever Catheter is advanced into the vessel andbeyond the clot. The self-expanding braided nitinol wire netis deployed. The expanded net cores, separates, and entrapsthrombus from the vessel as it is being drawn to the funnelopening of the ClotTriever Sheath. The net is collapsed andpulled into and through the ClotTriever Sheath with theentrapped clot. A 60 cc syringe is provided for the aspirationof clot in the sheath and the infusion of contrast media andother fluids. | The dilator is advanced over a standard 0.035"guidewire into the access site prior to placement of atherapeutic or diagnostic device. |
| Guidewire compatibility | 0.035" | 0.035" | 0.035" |
| How provided | Sterile, single use | Sterile, single use | Sterile, single use |
| Pre-dilator | 13 Fr ClotTriever Sheath: 16 Fr Pre-dilator16 Fr ClotTriever Sheath: 19 Fr Pre-dilator | Recommended accessory | 3 Fr to 26 Fr |
| Pre-dilator material | LDPE/HDPE | Not provided | LDPE/HDPE |
§ 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).