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 Description

The Intri24 Sheath is a single-use, sterile medical device for use in the peripheral vasculature. The Intri24 Sheath is an introducer sheath consisting of a short single lumen catheter with a hydrophilic coating, proximal hemostasis valve, and stopcock with flush port. A radiopaque marker is positioned near the distal tip of the sheath to aid with fluoroscopic visualization. The Intri24 Dilator is compatible with a 0.035" guidewire and has a tapered leading edge which aids insertion and positioning of the Intri24 Sheath.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the "Intri24 Sheath." It details the device's characteristics, indications for use, comparison to a predicate device, and the non-clinical testing performed to establish substantial equivalence.

However, the nature of the device (a catheter introducer sheath) means that the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are based on physical and functional performance tests rather than AI model performance or diagnostic accuracy. Therefore, the questions related to AI-specific metrics (like sample size for test/training sets, experts for ground truth, MRMC studies, standalone algorithm performance, and effect size for human readers) are not applicable to this type of device submission.

The "study" that proves the device meets acceptance criteria in this context refers to the non-clinical testing performed.

Here's how to interpret the provided information in the context of the device:

1. A table of acceptance criteria and the reported device performance:

The document describes various non-clinical tests performed and states that "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications." While the specific numerical acceptance criteria values are not provided in this summary, the types of tests conducted represent the areas where acceptance criteria would be set.

Acceptance Criteria Category (Test Type)	Reported Device Performance
Material & Physical Properties
Visual and Dimensional Inspection	Met acceptance criteria
Dye Staining	Met acceptance criteria
Lubricity and Durability	Met acceptance criteria
Kink Radius and Dilator Retraction Force	Met acceptance criteria
Tensile, Compression, and Torque Testing	Met acceptance criteria
Functional Performance
Guidewire Compatibility	Met acceptance criteria
Insertion Force	Met acceptance criteria
Locking Cap Force	Met acceptance criteria
Leak Testing	Met acceptance criteria
Simulated Use	Met acceptance criteria
Flowrate Testing	Met acceptance criteria
Vacuum Testing	Met acceptance criteria
Sheath Burst	Met acceptance criteria
Push-Button Force	Met acceptance criteria
Placement Resistance Testing	Met acceptance criteria
Biocompatibility
L-929 MEM Elution	Successfully passed
Kligman Maximization	Successfully passed
Intracutaneous Injection	Successfully passed
Systemic Injection	Successfully passed
Pyrogen	Successfully passed
Blood Hemolysis	Successfully passed
Complement Activation	Successfully passed
Thromboresistance	Successfully passed
Platelet and Leukocyte Count	Successfully passed
Partial Thromboplastin Time	Successfully passed
Sterility & Packaging
Pouch Seal Visual Inspection and Dye Penetration	Met acceptance criteria
Pouch, Peel, Seal Strength	Met acceptance criteria
Sterilization Validation	Met acceptance criteria

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not specify the exact sample sizes for each non-clinical test. This information would typically be detailed in the full test reports, not necessarily in a 510(k) summary. For physical device testing, sample sizes are often determined by statistical methods or industry standards (e.g., ISO, ASTM) to provide sufficient confidence in the results.
Data Provenance: The data is from non-clinical (benchtop) testing conducted by Inari Medical, Inc. The country of origin for the data is implicitly the USA (based on the company's address in Irvine, California, and the FDA submission). It is a prospective generation of data through controlled laboratory experiments.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable: For this type of physical medical device, "ground truth" is established by direct measurement against engineering specifications and industry standards, not by expert consensus on, for example, diagnostic images. The performance metrics are objectively measurable (e.g., force, flow rate, dimensions).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable: Adjudication methods like 2+1 or 3+1 are used for consensus-based ground truth in AI/imaging studies. Here, the "ground truth" is determined by established measurement techniques and calibrated equipment.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not Applicable: This device is a catheter introducer sheath, not an AI-powered diagnostic tool. Therefore, MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable: This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Objective Measurement/Engineering Specifications/Industry Standards: The "ground truth" for this device's performance is derived from its design specifications, established industry standards (such as ISO 10993 for biocompatibility), and physical measurements using calibrated equipment.

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" or corresponding ground truth establishment process for this device as it is not an AI/machine learning device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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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.6001 Oak Canyon, Suite 100Irvine, CA 92618877-923-4747
Contact person	Kit CariquitanVice President, Regulatory Affairs & Quality Assurance
Name of Device	Intri24 Sheath
Common name	Introducer Sheath
Regulation name	Catheter Introducer
Classificationnumber	21 CFR 870.1340
Product code	DYB
Regulatory class	II
Predicate device	W.L. Gore DrySeal Sheath with Hydrophilic Coating (K121234)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 theperipheral vasculature. The Intri24 Sheath is an introducer sheathconsisting of a short single lumen catheter with a hydrophilic coating,proximal hemostasis valve, and stopcock with flush port. A radiopaquemarker is positioned near the distal tip of the sheath to aid withfluoroscopic visualization. The Intri24 Dilator is compatible with a0.035" guidewire and has a tapered leading edge which aids insertionand positioning of the Intri24 Sheath.
Indications for Use	The Intri24 Sheath is indicated to provide a conduit for the insertion ofendovascular devices into the vasculature while minimizing blood lossassociated with such insertions.
Comparison ofTechnologicalCharacteristics withthe Predicate Device	The indications for use and principles of operation of the Intri24 Sheathand the predicate device are substantially the same. Both devices actas conduit for the insertion and removal of endovascular devices. Thedesign and materials of construction of both devices is alsosubstantially the same. The shafts of both devices contain a hydrophiliccoating to reduce the insertion force through skin and tissue. Bothsheaths also include an appropriately sized dilator (0.035 in guidewirecompatible) with a tapered tip to aid in dilation of the target vessel wheninserting the sheath.The Intri24 Sheath contains a user-actuated hemostasis valve identicalto that used on the ClotTriever catheter and sheath (K180329). Thehemostasis valve on the Intri24 Sheath allows for inserting orwithdrawing endovascular devices through the sheath. The useractuated hemostasis valve is operated by spring-loaded push buttons.The W.L. Gore DrySeal hemostasis valve contains an inflatable ringwhich closes when saline is injected and opens when saline iswithdrawn from the ring.
Summary ofsubstantialequivalence	The Intri24 Sheath's design, materials, mechanism of action, andperformance specifications are substantially equivalent to the predicatedevice.Non-Clinical TestingIn accordance with the Design Failure Modes and Effects Analysis,verification and validation testing were identified to support thesubstantial equivalence of the Intri24 Sheath. This testing demonstratedcompliance with relevant product specifications. These tests included: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●
Pouch, Peel, Seal Strength●
Sterilization Validation●
Biocompatibility Testing
The following biocompatibility tests were conducted in accordancewith ISO 10993-1:2018 and successfully passed:
L-929 MEM Elution
Kligman Maximization●
Intracutaneous Injection●
Systemic Injection●
Pyrogen●
Blood Hemolysis●
Complement Activation●
Thromboresistance●
Platelet and Leukocyte Count●
Partial Thromboplastin Time●
Animal and clinical testing were not required for the determination ofsubstantial equivalence.
Test results demonstrated that all acceptance criteria were met;therefore, the device conforms to established product specifications.
Conclusion
testing demonstrated that the Intri24Non-clinicalSheath issubstantially equivalent to the W.L. Gore DrySeal Sheath withHydrophilic Coating with respect to design, materials, function, andintended use.

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Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).