(18 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 Sheaths are indicated for use as a conduit for the insertion of endovascular devices into the vasculature while minimizing blood loss associated with such insertions.
The ClotTriever Thrombectomy System ("ClotTriever System") is a single-use over-the-wire catheter-based system used for the minimally invasive treatment of thromboemboli in the peripheral vasculature. The system consists of ClotTriever Catheters, ClotTriever Sheaths and Protrieve Sheath, each packaged separately. The ClotTriever Sheath consist of a polymeric shaft with a distal self-expanding nitinol mesh funnel, a proximal hub with a hemostasis valve and a sideport tubing. The mesh funnel is deployed by retracting the slide actuator back until it snaps into place. The mesh funnel self-expands to the diameter of the vessel and serves as a backstop as clot is removed through the lumen of the sheath. A hemostasis valve is integrated into the proximal hub of the sheath to prevent blood loss from devices passing through it. The sideport tubing has a large-bore stopcock and a terminal quick-disconnect coupling for connection to the Large Bore 60 cc Syringe for the aspiration of clot. A pre-dilator is provided with the ClotTriever Sheaths, to expand the target vessel prior to sheath insertion. A dilator is provided to aid insertion and positioning of the sheath, while the loading tool facilitates insertion of the mesh funnel into the dilator.
Here's an analysis of the provided FDA 510(k) summary regarding the ClotTriever Sheath, focusing on "acceptance criteria" and "study that proves the device meets the acceptance criteria."
Important Note: The provided document is a 510(k) clearance letter and summary for a medical device (ClotTriever Sheath). It is not a typical AI/Software as a Medical Device (SaMD) submission that would involve performance metrics like sensitivity, specificity, AUC, or a comparative effectiveness study with human readers assisting AI. Therefore, most of the requested information (sample size for test set, expert qualifications, MRMC study, standalone performance, training set details) will either be explicitly stated as "not applicable" or inferred from the nature of the device submission.
The "device" in this context is a physical medical device (catheter sheath), not an AI algorithm. The "acceptance criteria" and "performance" relate to its physical and functional characteristics, and its "study" refers to non-clinical (bench) testing, not clinical trials with human readers or AI algorithms.
Acceptance Criteria and Device Performance for ClotTriever Sheath
The acceptance criteria for the ClotTriever Sheath, as described in this 510(k) submission, are primarily centered around demonstrating substantial equivalence to a predicate device (Protrieve Sheath) through non-clinical performance characteristics, and the safety and effectiveness of the device for its indicated uses.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a physical device and not an AI algorithm, the "acceptance criteria" are typically defined by engineering specifications, material properties, and functional performance benchmarks to ensure safety and effectiveness for its intended use. The "reported device performance" is demonstrated through verification testing.
| Acceptance Criterion (Implicit from comparison & non-clinical testing) | Reported Device Performance (as demonstrated by testing) |
|---|---|
| Intended Use & Indications for Use Equivalence | The modified Indications for Use for the ClotTriever Sheath are stated to be substantially equivalent to the predicate Protrieve Sheath: "use as a conduit for the insertion of endovascular devices into the vasculature while minimizing blood loss associated with such insertions." The broader ClotTriever Thrombectomy System (which the sheath is part of) also maintains indications for non-surgical removal of thrombi/emboli and injection/aspiration of fluids in peripheral vasculature. The submission states the indications for use are the same as the predicate except for the additional "ClotTriever Sheaths" wording. |
| Technological Characteristics Equivalence | The ClotTriever Sheath has similar principles of operation and technological characteristics compared to the predicate Protrieve Sheath (e.g., guidewire compatibility of 0.035", sterilization method of SAL 10-6 and EtO, 2-year shelf-life). While dimensions differ (ClotTriever Sheath: 13 Fr ID - 0.180", 16 Fr ID - 0.215"; Protrieve Sheath: ID - 0.270"), these differences are implicitly acceptable as they satisfy the defined purpose and do not raise new safety or effectiveness concerns according to the FDA. |
| Functional Performance (e.g., conduit function, blood loss minimization) | The submission explicitly states: "Verification testing provided in K180329 and K192036 remains applicable to support use of the ClotTriever Sheaths as conduits for the insertion of endovascular devices into the peripheral vasculature." This implies that the prior non-clinical testing for the ClotTriever System (which includes the sheath) already demonstrated its ability to function as a conduit and minimize blood loss, and these results are considered valid for the current modification. The summary states that "the change to the Indications for Use does not raise new or different questions of safety and effectiveness." This is the primary "acceptance criterion" for this type of submission. |
| Biocompatibility | Not explicitly detailed in the provided snippet but implied. All medical devices coming into contact with the body must undergo biocompatibility testing (e.g., cytotoxicity, irritation, sensitization). Given previous clearances (K180329 and K192036), these tests would have been performed and the materials found to be biocompatible. |
| Sterility | Achieved by SAL 10-6, EtO sterilization method, as stated for both subject and predicate devices. This indicates that the sterility acceptance criteria (e.g., no microbial contamination) are met. |
| Shelf-Life / Stability | 2 years, as stated for both subject and predicate devices. This implies that the device maintained its functional integrity and sterility for this duration during stability testing. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. For a physical device like a sheath, the "test set" would typically refer to the number of devices or components tested during non-clinical verification. This number is not specified in the provided summary, as it's typically found in detailed test reports, not the 510(k) summary itself. The summary only refers to "Verification testing provided in K180329 and K192036."
- Data Provenance: Not applicable in the context of human data. The testing mentioned in the previous 510(k)s (K180329 and K192036) would be non-clinical (bench and potentially animal) testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable. This submission is for a physical medical device, not an AI/SaMD. "Ground truth" in this context refers to engineering specifications and performance benchmarks, not expert annotations of medical images or data.
4. Adjudication Method for the Test Set
- Not applicable. This relates to expert review for AI/SaMD and is not relevant for this physical device submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size (e.g., human readers improve with AI vs without AI assistance)
- No, not applicable. This is a physical device, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, not applicable. This is a physical device, not a standalone algorithm.
7. The Type of Ground Truth Used
- Engineering specifications and documented performance characteristics. For medical devices, the "ground truth" for non-clinical testing refers to established engineering standards, material properties, functional requirements, and safety benchmarks (e.g., burst pressure, tensile strength, flow rates, biocompatibility results), along with performance observed in simulated-use environments (e.g., flow models). The comparison to the predicate device also establishes a "ground truth" of already cleared and accepted performance.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" as this is not an AI/Machine Learning device.
9. How the Ground Truth for the Training Set was Established
- Not applicable. There is no "training set" as this is not an AI/Machine Learning device.
In summary, this 510(k) pertains to a non-active, physical medical device (catheter sheath). The "acceptance criteria" and "proof" primarily stem from demonstrating substantial equivalence to a legally marketed predicate device (Protrieve Sheath) based on shared intended use, similar technological characteristics, and prior non-clinical verification testing, without raising new questions of safety or effectiveness. The questions about AI-specific validation metrics are not applicable here.
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December 18, 2023
Inari Medical, Inc. Tosan Eweka Principal Regulatory Affairs Specialist 6001 Oak Canyon, Suite 100 Irvine. California 92618
Re: K233815
Trade/Device Name: ClotTriever Sheath Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, KRA, DYB Dated: November 30, 2023 Received: November 30, 2023
Dear Tosan Eweka:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Image /page/1/Picture/6 description: This image shows the name Gregory W. O'connell -S. The image also shows that it was digitally signed by Gregory W. O'connell -S on 2023.12.18. The time stamp is 11:55:40 -05'00'.
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
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Indications for Use
510(k) Number (if known) K233815
Device Name ClotTriever Sheath
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 Thrombectorny System is in the peripheral vasculature including deep vein thrombosis (DVT).
The ClotTriever Sheaths are indicated for use as a conduit for the insertion of endovascular devices into the vasculature while minimizing blood loss associated with such insertions.
| 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 | November 30, 2023 |
|---|---|
| Name | Inari Medical, Inc.6001 Oak Canyon, Suite 100Irvine, CA 92618949.600.8433 |
| Contact person | Tosan EwekaPrincipal Regulatory Affairs Specialist |
| Trade Name | ClotTriever Sheath |
| Device Name | ClotTriever Sheath |
| Common name | Embolectomy catheter |
| Regulation name | Embolectomy catheter |
| Classificationnumber | 21 CFR 870.5150 |
| Product code | QEW, KRA, DYB |
| Regulatory class | II |
| Predicate device | Protrieve Sheath (K230331) |
| Description | The ClotTriever Thrombectomy System ("ClotTriever System") is a single-use over-the-wire catheter-based system used for the minimally invasive treatment ofthromboemboli in the peripheral vasculature. The system consists of ClotTrieverCatheters, ClotTriever Sheaths and Protrieve Sheath, each packaged separately.The ClotTriever Sheath consist of a polymeric shaft with a distal self-expandingnitinol mesh funnel, a proximal hub with a hemostasis valve and a sideport tubing.The mesh funnel is deployed by retracting the slide actuator back until it snaps intoplace. The mesh funnel self-expands to the diameter of the vessel and serves as abackstop as clot is removed through the lumen of the sheath. A hemostasis valve isintegrated into the proximal hub of the sheath to prevent blood loss from devicespassing through it. The sideport tubing has a large-bore stopcock and a terminal quick-disconnect coupling for connection to the Large Bore 60 cc Syringe for the aspirationof clot. A pre-dilator is provided with the ClotTriever Sheaths, to expand the targetvessel prior to sheath insertion. A dilator is provided to aid insertion and positioningof the sheath, while the loading tool facilitates insertion of the mesh funnel into thedilator. |
| 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 intoor from a blood vessel.The ClotTriever Thrombectomy System is intended for use in the peripheralvasculature including deep vein thrombosis (DVT). |
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| DeviceModifications | The ClotTriever Sheaths are indicated for use as a conduit for the insertion ofendovascular devices into the vasculature while minimizing blood loss associatedwith such insertions. | ||
|---|---|---|---|
| DeviceModifications | The purpose of this submission is to modify the indications for use statement toinclude use of the ClotTriever Sheaths as conduits for the insertion of endovasculardevices into the vasculature while minimizing blood loss associated with suchinsertions. | ||
| Summary ofsubstantialequivalence | The subject device and predicate device have the same intended use and indicationsfor use. Both devices are intended to be used as conduits for the insertion ofendovascular devices into the vasculature while minimizing blood loss associatedwith such insertions. The subject device has the same principle of operation andsimilar technological characteristics as the predicate device. A tabular comparisonbetween the predicate and subject device is provided below: | ||
| ClotTriever Sheaths(Subject Device) | Protrieve Sheath(Predicate Device) | ||
| Manufacturer | Inari Medical, Inc. | Inari Medical, Inc. | |
| ModelDesignators | 50-101 (13 Fr ClotTrieverSheath)51-101 (16 Fr ClotTrieverSheath) | 60-101 (20 Fr ProtrieveSheath) | |
| Product Code | QEW, KRA, DYB | QEW, KRA, DYB | |
| Indications forUse | The ClotTrieverThrombectomy System isindicated for:• The non-surgical removalof thrombi and emboli fromblood vessels.• Injection, infusion, and/oraspiration of contrast mediaand other fluids into or froma blood vessel.The ClotTrieverThrombectomy System isintended for use in theperipheral vasculatureincluding deep veinthrombosis (DVT).The ClotTriever Sheaths areindicated for use as a conduit | The ClotTrieverThrombectomy System isindicated for:• The non-surgical removalof thrombi and emboli fromblood vessels.• Injection, infusion, and/oraspiration of contrast mediaand other fluids into or froma blood vessel.The ClotTrieverThrombectomy System isintended for use in theperipheral vasculatureincluding deep veinthrombosis (DVT).The Protrieve Sheath isindicated for use as a conduit | |
| for the insertion ofendovascular devices intothe vasculature whileminimizing blood lossassociated with suchinsertions. | for the insertion ofendovascular devices intothe vasculature whileminimizing blood lossassociated with suchinsertions. | ||
| Principles ofOperation | The ClotTriever Sheath anddilator are inserted over apre-placed 0.035" guidewireinto the vessel. Underfluoroscopic guidance, theSheath's mesh funnel isdeployed proximal to thethrombus targeted forextraction. Afterdeployment of the funnel,the dilator is withdrawnthrough the Sheath and fromthe patient entirely. Thecatheter or otherendovascular device is thenadvanced over the guidewirethrough the ClotTrieverSheath to the targetedtreatment site. Following thediagnostic or therapeuticprocedure, the endovasculardevice is retracted throughthe ClotTriever Sheath andremoved from the patient.The user-actuatedhemostasis valve integratedinto the Sheath hub allowsfor Insertion and withdrawalof endovascular devices. | The Protrieve Sheath anddilator are inserted over apre-placed 0.035" guidewireinto the vessel. Underfluoroscopic guidance, theSheath's mesh funnel isdeployed proximal to thethrombus targeted forextraction. After deploymentof the funnel, the dilator iswithdrawn through theSheath and from the patiententirely. The catheter orother endovascular device isthen advanced over theguidewire through theProtrieve Sheath to thetargeted treatment site.Following the diagnostic ortherapeutic procedure, theendovascular device isretracted through theProtrieve Sheath andremoved from the patient.The user-actuated hemostasisvalve integrated into theSheath hub allows forInsertion and withdrawal ofendovascular devices. | |
| Target Vessel | Peripheral vessels | Peripheral vessels | |
| Guidewirecompatibility | 0.035" | 0.035" | |
| Sheath shaftID/OD | 13 Fr ID - 0.180"16 Fr ID - 0.215"13 Fr OD - 0.210"16 Fr OD - 0.248" | ID - 0.270"OD - 0.345" | |
| Sheath length(deployed) | 15 cm | 32 cm | |
| Dilator OD | 13 Fr Sheath - 0.178" | 0.264" | |
| 16 Fr Sheath - 0.206" | |||
| Dilator Length | 10" | 25" | |
| Sterilization | SAL 10-6, EtO | SAL 10-6, EtO | |
| Shelf-Life | 2 years | 2 years | |
| Non-Clinical Testing | |||
| Verification testing provided in K180329 and K192036 remains applicable to supportuse of the ClotTriever Sheaths as conduits for the insertion of endovasculardevices into the peripheral vasculature. | |||
| Clinical Testing | |||
| Clinical testing was not required to support substantial equivalence. | |||
| Conclusion | |||
| The change to the Indications for Use does not raise new or different questions ofsafety and effectiveness. Results from previously conducted verification testingdemonstrate that the subject device is substantially equivalent to the predicate device.The subject device is therefore substantially equivalent to the predicate device. |
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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).