(71 days)
The FlowTriever Retrieval/Aspiration System is indicated 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 FlowTriever Retrieval/Aspiration System is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.
The FlowTriever Retrieval/Aspiration System is a single-use over-the-wire catheter-based system for the minimally invasive treatment of thromboemboli in the peripheral vasculature and for the treatment of pulmonary embolism. The system is comprised of two main components packaged separately:
• Triever Catheters (available in 3 sizes: 16, 20, and 24 Fr)
• FlowTriever Catheters (available in 4 sizes: 6-10 mm, 11-14 mm, 15-18 mm, and 19-25 mm)
The FlowTriever Catheter is inserted through the Triever Catheter and advanced to the thrombus. Self-expanding wireform disks are deployed to engage thrombus by retracting the outer delivery catheter. The FlowTriever Catheter is retracted into the Triever Catheter to capture the targeted thrombus. Additional clot may be removed by aspiration with the provided 60 cc VacLok Vacuum syringe. After the procedure is complete, the Triever Catheter and FlowTriever Catheter are removed from the patient.
The provided text describes a 510(k) summary for the Inari FlowTriever Retrieval/Aspiration System (K191710). This document is a premarket notification for a medical device and is primarily focused on demonstrating substantial equivalence to a predicate device, rather than detailed acceptance criteria and performance data typically found in a clinical study report for an AI-powered device.
Therefore, many of the requested points regarding acceptance criteria, study design, expert involvement, and ground truth for an AI device are not applicable or cannot be extracted from this particular document.
However, I can extract information related to the device's performance based on the non-clinical testing performed to support substantial equivalence.
Here's a summary of the available information:
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 specific numerical acceptance criteria or detailed performance metrics for each test. The tests performed are verification and validation tests to ensure the modified device meets specified requirements.
| Test Item | Acceptance Criteria (Not explicitly stated with values) | Reported Device Performance (Implied) |
|---|---|---|
| Visual & Dimensional Inspection | Conforms to specifications | Met |
| Guidewire and Sheath Compatibility | Compatible with specified guidewires and sheaths | Met |
| Snap Fit, Dilator Luer to Guide Catheter | Secure fit and proper function | Met |
| Hemostasis Valve Leakage Testing | No leakage under specified conditions | Met |
| Vacuum Testing | Maintains vacuum under specified conditions | Met |
| Air leakage During Aspiration | No air leakage during aspiration | Met |
| Retraction Force Testing | Within specified force limits | Met |
| Kink Radius Testing | Resists kinking at specified radius | Met |
| Determination of Flowrate | Achieves specified flow rate | Met |
| Burst Testing | Withstands specified pressure without bursting | Met |
| Clot Burden Removal Validation | Effective in clot removal (details not provided) | Met |
| Push Button Force | Within specified force range for activation | Met |
| Simulated Use and Tensile Testing | Withstands simulated use and tensile forces | Met |
| Simulated Use and Torque | Functions correctly under simulated use and torque | Met |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a number of "samples" in a traditional clinical study sense. The testing involved various non-clinical engineering and bench tests, as well as an animal study. The number of units or repetitions for each test is not provided.
- Data Provenance: The testing was "non-clinical testing" and "animal testing." No human data or specified country of origin for data is mentioned. It is implied the testing was conducted by the manufacturer, Inari Medical, Inc.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Not Applicable. This document describes the evaluation of a medical device (embolectomy catheter) through non-clinical and animal testing, not an AI or imaging device requiring expert ground truth for a test set.
4. Adjudication Method for the Test Set
- Not Applicable. As above, the document details non-clinical and animal testing, not a study involving human readers or requiring adjudication for a test set in the context of AI.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- No. This document does not mention any MRMC study or AI assistance. The device is a physical medical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI algorithm.
7. The Type of Ground Truth Used
- For Non-Clinical Tests: Engineering specifications, physical measurements, and performance standards.
- For Animal Testing: Observation of device safety and performance in an animal model.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI device trained on a dataset.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As above, this is not an AI device.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 5, 2019
Inari Medical Eben Gordon Vice President, RA/QA 9272 Jeronimo Rd., Suite 124 Irvine, California 92618
Re: K191710
Trade/Device Name: FlowTriever Retrieval/Aspiration System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: OEW Dated: July 9, 2019 Received: July 11, 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 (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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K191710
Device Name FlowTriever Retrieval/Aspiration System
Indications for Use (Describe)
The FlowTriever Retrieval/Aspiration System is indicated 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 FlowTriever Retrieval/Aspiration System is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.
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 | June 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 | FlowTriever Retrieval/Aspiration System |
| 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 (K191368) |
| Reference devices | Inari FlowTriever Retrieval/Aspiration System (K173672)Inari FlowTriever Retrieval/Aspiration System (K181325) |
| Description | The FlowTriever Retrieval/Aspiration System is a single-use over-the-wirecatheter-based system for the minimally invasive treatment of thromboemboli inthe peripheral vasculature and for the treatment of pulmonary embolism. Thesystem is comprised of two main components packaged separately:• Triever Catheters (available in 3 sizes: 16, 20, and 24 Fr)• FlowTriever Catheters (available in 4 sizes: 6-10 mm, 11-14 mm, 15-18mm, and 19-25 mm)The FlowTriever Catheter is inserted through the Triever Catheter and advancedto the thrombus. Self-expanding wireform disks are deployed to engage thrombusby retracting the outer delivery catheter. The FlowTriever Catheter is retractedinto the Triever Catheter to capture the targeted thrombus. Additional clot may beremoved by aspiration with the provided 60 cc VacLok Vacuum syringe. After theprocedure is complete, the Triever Catheter and FlowTriever Catheter areremoved from the patient. |
| Indications for Use | The FlowTriever Retrieval/Aspiration System is indicated 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 FlowTriever Retrieval/Aspiration System is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism. |
| Device modifications | The device modifications proposed are associated with increasing the Triever Catheter from 20 to 24 Fr. Specifically, these changes are: Catheter ID increase of 0.048" Catheter OD increase of 0.046" Proximal shaft material durometer changed to 72D 6.4 cm of the proximal shaft material replaced with 55D Pebax Dilator shaft OD increase of 0.048" |
| Summary of substantial equivalence | There is no change of intended use or fundamental scientific technology between the proposed and predicate device. The FlowTriever Retrieval/Aspiration System has the same indication for use as the predicate, K191368.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 modified FlowTriever Retrieval/Aspiration System. This testing demonstrated compliance with relevant product specifications. These tests included: Visual & Dimensional Inspection - Triever24 Catheter/dilator Guidewire and Sheath Compatibility Verification Snap Fit, Dilator Luer to Guide Catheter Hemostasis Valve Leakage Testing – Triever24 Catheter/ Dilator Vacuum Testing – Triever24 Catheter Air leakage During Aspiration – Triever24 Catheter Retraction Force Testing Kink Radius Testing Determination of Flowrate Burst Testing – Triever24 Catheter/Dilator Clot Burden Removal Validation Push Button Force Simulated Use and Tensile Testing - Triever24 Large Bore Syringe Simulated Use and Tensile Testing – Triever24 Catheter/Dilator Simulated Use and Torque |
| Animal testing confirmed the safety and performance of the Triever24 Catheter. | |
| Clinical testing was not required for the determination of substantial equivalence. | |
| Test results demonstrated that all acceptance criteria were met; therefore, the deviceconforms to established product specifications. | |
| Conclusion | |
| The proposed device modifications to the FlowTriever Retrieval/Aspiration Systemdo not change its intended use nor does it change the principles of operation. Withconsideration of the results of the testing leveraged from K191368, it can beconcluded that the proposed FlowTriever Retrieval/Aspiration System issubstantially equivalent to the predicate device. |
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K191710
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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).