(28 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 Protrieve Sheath is indicated for use as a conduit for the insertion of endovascular devices into the vasculature while minimizing blood loss associated with such insertions.
The Protrieve Sheath is a sterile, single-use over-the-wire introducer sheath with a hydrophilic coating, distal self-expanding funnel, aspiration port, and proximal hub. A dilator is provided to aid insertion and positioning of the sheath. Other provided accessories include a 60 cc large bore syringe that provides a vacuum source and collects aspirated contents. Radiopaque markers aid sheath positioning under fluoroscopic visualization. The dilator tip is radiopaque, and there is a radiopaque marker band near the distal end of the sheath. Target vessels include, but are not limited to, the iliofemoral, upper and lower extremity, inferior vena cava (IVC), and superior vena cava (SVC).
The FDA document for the Protrieve Sheath (K230331) details acceptance criteria and performance data primarily for non-clinical testing related to a design modification. The submission emphasizes substantial equivalence to a predicate device and an expansion of the Indications for Use.
It's important to note that this document does not describe a study involving AI assistance for human readers, nor does it detail a standalone algorithm performance study. The device in question is a medical sheath, not an AI/ML powered diagnostic device. Therefore, many of the requested points, such as MRMC studies, expert ground truth for imaging, and training set details, are not applicable to this type of medical device submission.
Here's the information gleaned from the provided text regarding acceptance criteria and performance, as applicable to this medical device:
1. Table of Acceptance Criteria and Reported Device Performance
Device: Protrieve Sheath (K230331)
| Acceptance Criteria Category | Specific Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Functional Performance | Simulated Use, Flushing – Protrieve Sheath | Not explicitly stated in terms of specific numeric or qualitative thresholds for flushing. | "Test results demonstrated that all acceptance criteria were met." |
| Functional Performance | Leakage Testing – Protrieve Sheath | Not explicitly stated in terms of specific numeric or qualitative thresholds for leakage. | "Test results demonstrated that all acceptance criteria were met." |
| Mechanical Performance | Tensile Testing – Protrieve Sheath | Not explicitly stated in terms of specific numeric thresholds for tensile strength. | "Test results demonstrated that all acceptance criteria were met." |
Note: The document states that "verification tests were identified and performed only for the attributes impacted by the slide actuator modification to support substantial equivalence." This implies that the acceptance criteria for these tests were established to ensure the modified device performs comparably to the previous version and the predicate device. However, the specific quantitative or detailed qualitative criteria are not explicitly listed in the provided summary. The general statement "Test results demonstrated that all acceptance criteria were met" confirms successful performance against these internal criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify the exact number of units or test iterations conducted for the "Simulated Use, Flushing," "Leakage Testing," and "Tensile Testing." In non-clinical device testing, sample sizes are typically determined by statistical methods to ensure robustness and often align with recognized standards.
- Data Provenance: This was a non-clinical bench testing study, not a clinical study involving patient data. Therefore, data provenance in terms of country of origin or retrospective/prospective collection is not applicable. The testing was performed by Inari Medical, Inc. to support regulatory submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. This submission pertains to a physical medical device (introducer sheath) and its performance in non-clinical bench testing. There is no "ground truth" established by experts in the context of diagnostic outcomes or image interpretation, as would be relevant for an AI/ML-based device. The "ground truth" for these tests are the pre-defined performance specifications of the device.
4. Adjudication Method for the Test Set
- Not Applicable. As this is non-clinical bench testing, there is no need for expert adjudication of results. The results are typically quantitative measurements against pre-defined engineering specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is relevant for diagnostic devices, particularly those involving image interpretation where human readers' performance with and without AI assistance is compared. The Protrieve Sheath is an introducer sheath; therefore, an MRMC study was not performed. The document explicitly states "Clinical testing was not required to support substantial equivalence."
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This is not an AI/ML algorithm. Therefore, a standalone algorithm performance study was not conducted.
7. The Type of Ground Truth Used
- Engineering Specifications and Industry Standards: The "ground truth" for the non-clinical testing (Simulated Use, Flushing, Leakage, Tensile Testing) would be the device's technical specifications and relevant performance requirements derived from engineering design, risk analysis (FMEA), and applicable medical device standards. The statement "all acceptance criteria were met" indicates performance aligned with these pre-defined standards.
8. The Sample Size for the Training Set
- Not Applicable. This is a medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As per point 8, there is no training set for this type of medical device.
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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 & 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.
March 7, 2023
Inari Medical, Inc. Kaitlyn Weinkauf Sr. Regulatory Affairs Specialist 6001 Oak Canyon, Suite 100 Irvine, California 92618
Re: K230331
Trade/Device Name: Protrieve Sheath Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, KRA, DYB Dated: February 6, 2023 Received: February 7, 2023
Dear Kaitlyn Weinkauf:
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,
Digitally signed by Gregory W. Gregory W. O'connell O'connell -S Date: 2023.03.07 13:28:40 -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
Enclosure
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Indications for Use
510(k) Number (if known) K230331
Device Name Protrieve 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 intended for use in the peripheral vasculature including deep vein thrombosis (DVT).
The Protrieve Sheath is 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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PAGE 1 OF 6
510(K) SUMMARY
| Date prepared | March 6, 2023 |
|---|---|
| Name | Inari Medical, Inc.6001 Oak Canyon, Suite 100Irvine, CA 92618949-600-8433 |
| Contact person | Kaitlyn WeinkaufSr. Regulatory Affairs Specialist |
| Device Name | Protrieve™ Sheath |
| Trade Name | Protrieve™ Sheath |
| Common name | Embolectomy catheter |
| Regulation name | Embolectomy catheter |
| Classification number | 21 CFR 870.5150 |
| Primary product code | QEW |
| Secondary product codes | KRA, DYB |
| Regulatory class | II |
| Predicate device | Intri24™ Introducer Sheath (K212392) |
| Reference device | Protrieve™ Sheath (K220415) |
| Description | The Protrieve Sheath is a sterile, single-use over-the-wire introducer sheath with ahydrophilic coating, distal self-expanding funnel, aspiration port, and proximal hub. Adilator is provided to aid insertion and positioning of the sheath. Other providedaccessories include a 60 cc large bore syringe that provides a vacuum source andcollects aspirated contents. Radiopaque markers aid sheath positioning underfluoroscopic visualization. The dilator tip is radiopaque, and there is a radiopaquemarker band near the distal end of the sheath. Target vessels include, but are not limitedto, the iliofemoral, upper and lower extremity, inferior vena cava (IVC), and superiorvena cava (SVC). |
| 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 peripheral vasculature including deep vein thrombosis (DVT). |
devices into the vasculature while minimizing blood loss associated with such insertions.
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Device modifications The purpose of this submission is a design modification to the Protrieve Sheath slide actuator specifically and to expand the indications for use statement to include using the Protrieve Sheath as a conduit for the insertion of endovascular devices into the vasculature while minimizing blood loss associated with such insertions.
There are no proposed changes to the intended use of the Protrieve Sheath.
There are no proposed changes to the intended use and design of the ClotTriever/ClotTriever BOLD Catheter and ClotTriever Sheaths (13 Fr and 16 Fr).
Comparison of Technological Characteristics with the Predicate Device
The predicate Intri24 Introducer Sheath is indicated to "Provide a conduit for the insertion of endovascular devices into the vasculature while minimizing blood loss associated with such insertions." The proposed Protrieve Sheath's expanded indications for use are identical. Furthermore, the principles of operation and fundamental scientific technology of the proposed Protrieve Sheath and predicate device are substantially equivalent. Both devices act as a conduit for the insertion and removal of endovascular devices in the vasculature. The design and materials of construction of both devices are also substantially the same. The shafts of both devices contain a hydrophilic coating to reduce the insertion force through skin and tissue. Both sheaths also include an appropriately sized dilator (0.035" guidewire compatible) with a tapered tip to aid in dilation of the target vessel when inserting the sheath. Both sheaths contain a useractuated hemostasis valve that allows for inserting or withdrawing endovascular devices through the sheath while minimizing blood loss.
| Device | Protrieve Sheath(Proposed) | Intri24 Introducer SheathPredicate (K212392) | Protrieve SheathReference (K220415) |
|---|---|---|---|
| Manufacturer | Inari Medical | Inari Medical | Inari Medical |
| Product Code | QEW, KRA, DYB | DYB | QEW, KRA |
| Indications for Use | The ClotTrieverThrombectomy Systemis indicated for:• The non-surgicalremoval of thrombi andemboli from bloodvessels.• Injection, infusion,and/or aspiration ofcontrast media and otherfluids into or from ablood vessel.The ClotTrieverThrombectomy Systemis intended for use in theperipheral vasculatureincluding deep veinthrombosis (DVT).The Protrieve Sheath isindicated for use as aconduit for the insertionof endovascular devicesinto the vasculature | The Intri24 Introducer Sheath isindicated to provide a conduit forthe insertion of endovasculardevices into the vasculature whileminimizing blood loss associatedwith such insertions. | The ClotTrieverThrombectomy System isindicated for:• The non-surgical removal ofthrombi and emboli fromblood vessels.• Injection, infusion, and/oraspiration of contrast mediaand other fluids into or from ablood vessel.The ClotTrieverThrombectomy System isintended for use in theperipheral vasculatureincluding deep veinthrombosis (DVT). |
| while minimizing bloodloss associated with suchinsertions. | |||
| Device Description | The Protrieve Sheath is asingle-use, sterilemedical device for use inthe peripheralvasculature. TheProtrieve Sheath is anintroducer sheath with ahydrophilic coating,distal self-expandingfunnel, aspiration port,and proximal hub. Adilator is provided to aidinsertion and positioningof the sheath. Otherprovided accessoriesinclude a 60 cc largebore syringe thatprovides a vacuumsource and collectsaspirated contents.Radiopaque markers aidsheath positioning underfluoroscopicvisualization. The dilatortip is radiopaque, andthere is a radiopaquemarker band near thedistal end of the sheath. | The Intri24 Introducer Sheath is asingle-use, sterile medical devicefor use in the peripheralvasculature. The Intri24 IntroducerSheath is an introducer sheathconsisting of a short single lumencatheter with a hydrophilic coating,proximal hemostasis valve, andstopcock with flush port. Aradiopaque marker is positionednear the distal tip of the sheath toaid with fluoroscopic visualization.The Intri24 dilator is compatiblewith a 0.035" guidewire and has atapered leading edge which aidsinsertion and positioning of theIntri24 Sheath. | The Protrieve Sheath is asingle-use, sterile medicaldevice for use in theperipheral vasculature. TheProtrieve Sheath is anintroducer sheath with ahydrophilic coating, distalself-expanding funnel,aspiration port, and proximalhub. A dilator is provided toaid insertion and positioningof the sheath. Other providedaccessories include a 60 cclarge bore syringe thatprovides a vacuum sourceand collects aspiratedcontents. Radiopaque markersaid sheath positioning underfluoroscopic visualization.The dilator tip is radiopaque,and there is a radiopaquemarker band near the distalend of the sheath. |
| Principles of Operation | The Protrieve Sheath anddilator are inserted overa pre-placed 0.035"guidewire into thevessel. Underfluoroscopic guidance,the funnel is deployedproximal to the targetsite. The ProtrieveSheath funnel isdeployed by retractingthe sheath's slideactuator back until itsnaps into place. Oncethe funnel is deployed,the dilator is withdrawnthrough the sheath andfrom the patient entirely.TheClotTriever/ClotTriever | The Intri24 Introducer Sheath anddilator are inserted over a pre-placed 0.035" guidewire into thevessel towards the target treatmentsite using fluoroscopic imaging.After positioning, the dilator isdetached from the hemostasis valveand withdrawn from the patient. Anendovascular device is thenadvanced over the guidewirethrough the Intri24 IntroducerSheath to the targeted treatmentsite. Following the diagnostic ortherapeutic procedure, theendovascular device is retractedthrough the Intri24 IntroducerSheath and removed from thepatient. | The Protrieve Sheath anddilator are inserted over a pre-placed 0.035" guidewire intothe vessel. Underfluoroscopic guidance, thefunnel is deployed proximalto the target site. TheProtrieve Sheath funnel isdeployed by retracting thesheath's slide actuator backuntil it snaps into place. Oncethe funnel is deployed, thedilator is withdrawn throughthe sheath and from thepatient entirely. TheClotTriever/ClotTrieverBOLD Catheter is thenadvanced over the guidewirethrough the Protrieve Sheathto the targeted treatment site.The ClotTriever/ClotTriever |
| endovascular device isthen advanced over theguidewire through theProtrieve Sheath to thetargeted treatment site.Following the diagnosticor therapeutic procedure,the ClotTriever/ClotTriever BOLDCatheter or endovasculardevice is retractedthrough the ProtrieveSheath and removedfrom the patient. A 60 ccsyringe is provided forthe aspiration of clot inthe sheath and theinfusion of contrastmedia and other fluids. | BOLD Catheter with theentrapped clot is retractedthrough the Protrieve Sheathand removed from the patient.A 60 cc syringe is providedfor the aspiration of clot inthe sheath and the infusion ofcontrast media and otherfluids. | ||
| Target Vessel | Peripheral vasculature.Target vessels include,but are not limited to, theiliofemoral, upper andlower extremity, inferiorvena cava (IVC), andsuperior venacava(SVC). | Peripheral vasculature. | Peripheral vasculature.Target vessels include, but arenot limited to, the iliofemoral,upper and lower extremity,inferior vena cava (IVC), andsuperior vena cava (SVC). |
| Placement duration | < 24 hours | < 24 hours | < 24 hours |
| Sterilization | SAL 10-6, EO | SAL 10-6, EO | SAL 10-6, EO |
| Shelf-life | 2 years | 2 years | 2 years |
| How provided | Sterile, single use | Sterile, single use | Sterile, single use |
| Sheath shaft length | Undeployed length: 38cmDeployed length: 32 cm | 33 cm | Undeployed length: 32 cmDeployed length: 26 cm |
| Sheath shaft ID/OD | ID: 0.270"OD: 0.345" | ID: 0.314"OD: 0.344" | ID: 0.270"OD: 0.345" |
| Shaft coating | Hydrophilic coating | Hydrophilic coating | Hydrophilic coating |
| Sheath Shaft Materials | Proximal segment:Pebax 4533 (45D) SA 01MED, 4% Violet CHydrophilic Coating | Proximal segment:Pebax 4533 (45D) SA 01 MED,20% BaSO4, 4% Violet C,Hydrophilic Coating | Proximal segment:Pebax 4533 (45D) SA 01MED, 4% Violet CHydrophilic Coating |
| Distal segment:Pebax 3533 (35D) SA 01MED, Propel,4% Violet C | Distal segment:Pebax 6333 (63D) SA 01 MED,20% BaSO4, 4% Violet C | Distal segment:Pebax 3533 (35D) SA 01MED, Propel,4% Violet C | |
| Marker band | Platinum-iridium | Platinum-iridium | Platinum-iridium |
| Mesh Funnel | Length: 1.24"OD: 33.5 mmMaterial: 0.0067" Nitinolwire | N/A | Length: 1.24"OD: 33.5 mmMaterial: 0.0067" Nitinol wire |
| Dilator Materials | HDPE DMDA 8920+,2%Titanium dioxideLDPE 640i, 20% Bariumsulfate, 2% TitaniumdioxideABS, Cool Gray 6C | HDPE DMDA 8920+, 2%Titanium dioxideLDPE 640i, 20% Barium sulfate,2% Titanium dioxideABS, Cool Gray 6C | HDPE DMDA 8920+, 2%Titanium dioxideLDPE 640i, 20% Bariumsulfate, 2% Titanium dioxideABS, Cool Gray 6C |
| Dilator OD | 0.264" | 0.315" | 0.264" |
| Dilator Length | 25.15" | 18.78" | 22.96" |
| Sideport Tubing withStopcock and QuickConnect | Yes | Yes | Yes |
| Guidewire compatibility | 0.035" | 0.035" | 0.035" |
| Accessory | Large bore 60 cc syringe | N/A | Large bore 60 cc syringe |
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K230331
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K230331
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Summary of substantial equivalence
Non-Clinical Testing
In accordance with the design failure modes and effects analysis, verification tests were identified and performed only for the attributes impacted by the slide actuator modification to support substantial equivalence. Verification testing was not required for the expanded indications and the testing performed in K220415 remains applicable to support the use of the Protrieve Sheath as a conduit for the insertion of endovascular devices into the peripheral vasculature. The testing demonstrated compliance with relevant product specifications.
The following tests were performed for the slide actuator change on the proposed device to establish substantial equivalence:
- . Simulated Use, Flushing - Protrieve Sheath
- Leakage Testing - Protrieve Sheath
- Tensile Testing Protrieve Sheath ●
Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications.
Clinical Testing
Clinical testing was not required to support substantial equivalence.
Conclusion
The proposed design modification of the Protrieve Sheath slide actuator does not change its intended use or principles of operation. The verification results demonstrate that the proposed Protrieve Sheath is substantially equivalent to the predicate device.
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Expanding the indications for use statement to include using the Protrieve Sheath as a conduit for the insertion of endovascular devices into the vasculature while minimizing blood loss associated with such insertions aligns with the current use of the device. The Protrieve Sheath is an introducer sheath for the insertion and removal of thrombectomy catheters in the peripheral vasculature. Similarly, the expanded indication allows the Protrieve Sheath to act as a conduit for the insertion and removal of endovascular devices into the peripheral vasculature. The proposed indication for the Protrieve Sheath does not raise new or different questions of safety or effectiveness.
§ 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).