Intri24 Sheath

K212392 · Inari Medical, Inc. · DYB · Apr 1, 2022 · Cardiovascular

Device Facts

• Record ID: K212392
• Device Name: Intri24 Sheath
• Applicant: Inari Medical, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Apr 1, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Intri24 Sheath is indicated to provide a conduit for the insertion of endovascular devices into the vasculature while minimizing blood loss associated with such insertions.

Device Story

Intri24 Sheath is a single-use, sterile introducer sheath for peripheral vasculature. Device consists of a short single-lumen catheter with a hydrophilic coating, a proximal user-actuated hemostasis valve, and a stopcock with a flush port. A radiopaque marker at the distal tip aids fluoroscopic visualization. An included dilator, compatible with 0.035" guidewires, features a tapered leading edge to facilitate vessel insertion. The hemostasis valve, operated by spring-loaded push buttons, allows for the insertion or withdrawal of endovascular devices while maintaining hemostasis. Used in clinical settings by physicians to provide a conduit for endovascular procedures; benefits patient by facilitating device access and reducing blood loss.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including visual/dimensional inspection, lubricity/durability, guidewire compatibility, insertion/retraction forces, leak testing, flowrate, vacuum testing, sheath burst, and mechanical integrity (tensile, compression, torque). Biocompatibility testing conducted per ISO 10993-1:2018, including cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemolysis, complement activation, and thromboresistance.

Technological Characteristics

Single-lumen catheter with hydrophilic coating; includes dilator (0.035" guidewire compatible) and spring-loaded push-button hemostasis valve. Radiopaque distal marker. Materials meet ISO 10993-1:2018 biocompatibility standards. Sterile, single-use device.

Indications for Use

Indicated for patients requiring endovascular device insertion into the peripheral vasculature; provides conduit while minimizing blood loss.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• W.L. Gore DrySeal Sheath with Hydrophilic Coating (K121234)

Reference Devices

• ClotTriever Thrombectomy System (K180329)

Submission Summary (Full Text)

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April 1, 2022

Inari Medical, Inc. Kit Cariquitan Vice President, Regulatory Affairs 9 Parker. Suite 100 Irvine, California 92618

Re: K212392

Trade/Device Name: Intri24 Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: February 25, 2022 Received: February 28, 2022

#### Dear Kit Cariquitan:

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Finn Donaldson Assistant Director (Acting) 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) K212392

Device Name Intri24 Sheath

Indications for Use (Describe)

The Intri24 Sheath is indicated to provide 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 | July 29, 2021 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Inari Medical, Inc.<br>6001 Oak Canyon, Suite 100<br>Irvine, CA 92618<br>877-923-4747 |
| Contact person | Kit Cariquitan<br>Vice President, Regulatory Affairs & Quality Assurance |
| Name of Device | Intri24 Sheath |
| Common name | Introducer Sheath |
| Regulation name | Catheter Introducer |
| Classification<br>number | 21 CFR 870.1340 |
| Product code | DYB |
| Regulatory class | II |
| Predicate device | W.L. Gore DrySeal Sheath with Hydrophilic Coating (K121234)<br>This product has not been subject to a design-related recall. |
| Reference device | ClotTriever Thrombectomy System (K180329) |
| Description | The Intri24 Sheath is a single-use, sterile medical device for use in the<br>peripheral vasculature. The Intri24 Sheath is an introducer sheath<br>consisting of a short single lumen catheter with a hydrophilic coating,<br>proximal hemostasis valve, and stopcock with flush port. A radiopaque<br>marker is positioned near the distal tip of the sheath to aid with<br>fluoroscopic visualization. The Intri24 Dilator is compatible with a<br>0.035" guidewire and has a tapered leading edge which aids insertion<br>and positioning of the Intri24 Sheath. |
| Indications for Use | The Intri24 Sheath is indicated to provide a conduit for the insertion of<br>endovascular devices into the vasculature while minimizing blood loss<br>associated with such insertions. |
| Comparison of<br>Technological<br>Characteristics with<br>the Predicate Device | The indications for use and principles of operation of the Intri24 Sheath<br>and the predicate device are substantially the same. Both devices act<br>as conduit for the insertion and removal of endovascular devices. The<br>design and materials of construction of both devices is also<br>substantially the same. The shafts of both devices contain a hydrophilic<br>coating to reduce the insertion force through skin and tissue. Both<br>sheaths also include an appropriately sized dilator (0.035 in guidewire<br>compatible) with a tapered tip to aid in dilation of the target vessel when<br>inserting the sheath.<br><br>The Intri24 Sheath contains a user-actuated hemostasis valve identical<br>to that used on the ClotTriever catheter and sheath (K180329). The<br>hemostasis valve on the Intri24 Sheath allows for inserting or<br>withdrawing endovascular devices through the sheath. The user<br>actuated hemostasis valve is operated by spring-loaded push buttons.<br>The W.L. Gore DrySeal hemostasis valve contains an inflatable ring<br>which closes when saline is injected and opens when saline is<br>withdrawn from the ring. |
| Summary of<br>substantial<br>equivalence | The Intri24 Sheath's design, materials, mechanism of action, and<br>performance specifications are substantially equivalent to the predicate<br>device.<br><br>Non-Clinical Testing<br><br>In accordance with the Design Failure Modes and Effects Analysis,<br>verification and validation testing were identified to support the<br>substantial equivalence of the Intri24 Sheath. This testing demonstrated<br>compliance with relevant product specifications. These tests included:<br>Visual and Dimensional Inspection Dye Staining Lubricity and Durability Guidewire Compatibility Insertion Force Locking Cap Force Kink Radius and Dilator Retraction Force Leak Testing Simulated Use Flowrate Testing Vacuum Testing Sheath Burst Push-Button Force Tensile, Compression, and Torque Testing Placement Resistance Testing |
| | |
| Pouch Seal Visual Inspection and Dye Penetration<br>● | |
| Pouch, Peel, Seal Strength<br>● | |
| Sterilization Validation<br>● | |
| Biocompatibility Testing | |
| The following biocompatibility tests were conducted in accordance<br>with ISO 10993-1:2018 and successfully passed: | |
| L-929 MEM Elution | |
| Kligman Maximization<br>● | |
| Intracutaneous Injection<br>● | |
| Systemic Injection<br>● | |
| Pyrogen<br>● | |
| Blood Hemolysis<br>● | |
| Complement Activation<br>● | |
| Thromboresistance<br>● | |
| Platelet and Leukocyte Count<br>● | |
| Partial Thromboplastin Time<br>● | |
| Animal and clinical testing were not required for the determination of<br>substantial equivalence. | |
| Test results demonstrated that all acceptance criteria were met;<br>therefore, the device conforms to established product specifications. | |
| Conclusion | |
| testing demonstrated that the Intri24<br>Non-clinical<br>Sheath is<br>substantially equivalent to the W.L. Gore DrySeal Sheath with<br>Hydrophilic Coating with respect to design, materials, function, and<br>intended use. | |
| | |

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