(28 days)
The Triever20 Curve is used coaxially within the Triever24 for:
The non-surgical removal of emboli and thrombi from blood vessels.Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The Triever20 Curve is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.
The Triever20 Curve Catheter is not indicated for use with FlowTriever Catheters.
The Triever20 Curve is a single-use over-the-wire catheter used for the minimally invasive treatment of thromboemboli in the peripheral vasculature and for the treatment of pulmonary embolism.
The Triever20 Curve Catheter is inserted through the Triever24 Catheter and advanced to the thrombus. Thrombus is removed by aspiration with the provided 60 cc Large Bore Vacuum syringe. After the procedure is complete, the Triever Catheters are removed from the patient.
The provided text describes a 510(k) premarket notification for the Triever20 Curve Catheter. This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not describe a study involving an algorithm or artificial intelligence (AI).
Therefore, I cannot provide information on acceptance criteria and a study proving a device meets those criteria in the context of AI performance. The information requested regarding AI performance (sample size for test set, data provenance, number of experts for ground truth, adjudication, MRMC study, standalone performance, type of ground truth, training set size, and ground truth for training set) is not present in the provided document.
Instead, the document details non-clinical testing performed to demonstrate that modifications to the Triever20 Curve Catheter did not change its intended use or fundamental scientific technology, thereby demonstrating substantial equivalence to the predicate device (Inari FlowTriever Retrieval/Aspiration System, K191710).
Here's the relevant information about the acceptance criteria and the study performed, based only on the provided text, but explicitly noting its non-AI context:
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 or the specific numerical performance results. It lists the types of tests performed.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Compliance with relevant product specifications for various mechanical and functional aspects. | All acceptance criteria were met. The device conforms to established product specifications. |
Specific tests conducted (implying the acceptance criteria for each were met):
- Package Integrity Inspection
- Visual & Dimensional Inspection
- Guidewire and Dilator Compatibility Verification
- Triever20 Curve Dilator Insertion and Removal
- Triever20 Curve Insertion into Triever24 and Retraction
- Triever20 Curve Rotation inside Triever24
- Triever20 Curve recovery angle
- Kink Radius
- Torque Test 1
- Torque Test 2
- Resistance to collapse under vacuum
- Determination of Flowrate Through Catheters & Dilator Burst Testing – Triever20 Curve Catheter
- Clot Burden Removal Validation
- Simulated Use and Tensile Testing - Torque
- Simulated Use and Tensile Testing - Tensile
- Simulated Use and Tensile Testing – Triever20 Curve Dilator
- Particulate Matter Determination
Tests leveraged from K173672 (implying acceptance criteria for these were also met):
- Pouch Seal Visual Inspection and Dye Penetration
- Pouch, Peel, Seal Strength
- Test Conical Fittings with 6% Luer taper
- Corrosion Resistance
- No air bubbles from fluid drawback
- Hemostasis
- Priming of the system
- Snap fit
- Sufficient vacuum
- Pyrogenicity
- Device Insertion
- Luer Lock Connection
- Dilator: Hub to Shaft attachment; Proximal shaft to Distal shaft attachment; Tip to Shaft attachment
- Hub and Catheter Leakage
- Dilator Burst
2. Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated for each test. The document mentions "verification and validation testing" and "test results" in general but does not provide specific numbers of devices or tests conducted for each category.
- Data provenance: N/A, as this refers to non-clinical, in-vitro/benchtop testing of a physical medical device, not data for an AI algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was non-clinical engineering and performance testing of a physical device, not an AI algorithm requiring expert ground truth for image interpretation or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This refers to adjudication of expert opinions for AI ground truth, which is not relevant here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done:
- No, an MRMC study was not done. This type of study is specifically for evaluating the effectiveness of AI with human readers, which is not the subject of this document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. The device is a physical medical catheter, not an algorithm.
7. The type of ground truth used:
- The "ground truth" for this device's performance is based on established engineering and material specifications, regulatory standards, and the physical performance observed during the benchtop and in-vitro tests (e.g., flow rate measurements, tensile strength, burst pressure, clot removal efficacy in a simulated environment). It is not pathology, outcomes data, or expert consensus in an AI context.
8. The sample size for the training set:
- Not applicable. This document does not describe an AI algorithm that would require a training set.
9. How the ground truth for the training set was established:
- Not applicable. No training set was used for an AI algorithm.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 10, 2020
Inari Medical, Inc. Ellen Nguyen Regulatory Affairs Associate 9 Parker, Suite 100 Irvine, California 92618
Re: K203333
Trade/Device Name: Triever20 Curve Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW Dated: November 11, 2020 Received: November 12, 2020
Dear Ellen Nguyen:
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); 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 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)
Device Name Triever20 Curve Catheter
| Indications for Use (Describe) | The Triever20 Curve is used coaxially within the Triever24 for: |
|---|---|
| -------------------------------- | ----------------------------------------------------------------- |
- · The non-surgical removal of emboli and thrombi from blood vessels.
- · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The Triever20 Curve is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.
The Triever20 Curve Catheter is not indicated for use with FlowTriever Catheters.
| 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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PAGE 1 OF 3
510(K) SUMMARY
| Date prepared | November 11, 2020 | |
|---|---|---|
| Name | Inari Medical, Inc.9 Parker, Suite 100Irvine, CA 92618949.600.8433 | |
| Contact person | Ellen NguyenRegulatory Affairs Associate | |
| Trade name | Triever20 Curve Catheter | |
| Common name | Embolectomy catheter | |
| Regulation name | Embolectomy catheter | |
| Classification number | 21 CFR 870.5150 | |
| Product code | QEW | |
| Regulatory class | II | |
| Predicate device | Inari FlowTriever Retrieval/Aspiration System (K191710) | |
| Description | The Triever20 Curve is a single-use over-the-wire catheter used for the minimallyinvasive treatment of thromboemboli in the peripheral vasculature and for thetreatment of pulmonary embolism.The Triever20 Curve Catheter is inserted through the Triever24 Catheter andadvanced to the thrombus. Thrombus is removed by aspiration with the provided60 cc Large Bore Vacuum syringe. After the procedure is complete, the TrieverCatheters are removed from the patient. | |
| Indications for Use | The Triever20 Curve is used coaxially within the Triever24 for:The non-surgical removal of emboli and thrombi from blood vessels.Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.The Triever20 Curve is intended for use in the peripheral vasculature and for thetreatment of pulmonary embolism.The Triever20 Curve Catheter is not indicated for use with FlowTriever Catheters. | |
| Device modifications | The device modifications associated with implementing the Triever20 Curve with an angled tip: | |
| Proximal shaft durometer change from 63D Pebax to 72D Pebax Length of 35D Pebax distal shaft increased 7.6 cm (29.2 to 36.8 cm) 6.4 cm of 55D Pebax added between proximal and distal shaft segments 0.6 cm of 72D Pebax added to distal shaft tip Catheter length increase of 14.8 cm (90.2 cm to 105.0 cm) Catheter OD increase of 0.009" (0.257" to 0.266") Bonding the proximal Hemostasis Valve to render it non-rotatable Dilator length increase of 15 cm (96 to 111 cm) | ||
| Summary of substantial equivalence | There is no change of intended use or fundamental scientific technology between the proposed and predicate device. The Triever20 Curve has the same indication for use as the predicate, K191710. | |
| 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 Triever20 Curve. This testing demonstrated compliance with relevant product specifications. These tests included: | ||
| Package Integrity Inspection Visual & Dimensional Inspection Guidewire and Dilator Compatibility Verification Triever20 Curve Dilator Insertion and Removal Triever20 Curve Insertion into Triever24 and Retraction Triever20 Curve Rotation inside Triever24 Triever20 Curve recovery angle Kink Radius Torque Test 1 Torque Test 2 Resistance to collapse under vacuum Determination of Flowrate Through Catheters & Dilator Burst Testing – Triever20 Curve Catheter Clot Burden Removal Validation Simulated Use and Tensile Testing - Torque Simulated Use and Tensile Testing - Tensile Simulated Use and Tensile Testing – Triever20 Curve Dilator Particulate Matter Determination | ||
| The following testing was leveraged from K173672: | ||
| Pouch Seal Visual Inspection and Dye Penetration Pouch, Peel, Seal Strength | ||
| • | Test Conical Fittings with 6% Luer taper | |
| • | Corrosion Resistance | |
| • | No air bubbles from fluid drawback | |
| • | Hemostasis | |
| • | Priming of the system | |
| • | Snap fit | |
| • | Sufficient vacuum | |
| • | Pyrogenicity | |
| • | Device Insertion | |
| • | Luer Lock Connection | |
| • | Dilator: Hub to Shaft attachment; Proximal shaft to Distal shaft attachment; Tip to Shaft attachment | |
| • | Hub and Catheter Leakage | |
| • | Dilator Burst | |
| Animal testing was not required for the determination of substantial equivalence. | ||
| 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. | ||
| Conclusion | ||
| The proposed device modifications to the Triever20 Curve do 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 Triever20 Curve is substantially equivalent to the predicate device. |
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PAGE 3 OF 3
§ 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).