(242 days)
No
The device description and performance studies focus on the physical and mechanical properties of a simple introducer sheath, with no mention of AI/ML capabilities or data processing beyond basic visualization.
No.
The device description and intended use indicate that the Intri24 Sheath is a conduit for inserting other endovascular devices, not a device that directly treats a condition or disease itself. It facilitates a procedure but does not have a therapeutic effect.
No
Explanation: The Intri24 Sheath is described as an introducer sheath used to provide a conduit for the insertion of other endovascular devices. Its purpose is to facilitate access and minimize blood loss during these procedures, not to diagnose a condition. The "Indications for Use" section clearly states its role as a "conduit for the insertion of endovascular devices."
No
The device description clearly outlines a physical introducer sheath with various hardware components (catheter, valve, stopcock, radiopaque marker, dilator). The performance studies also detail extensive physical and material testing, not software validation.
Based on the provided information, the Intri24 Sheath is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide a conduit for inserting endovascular devices into the vasculature. This is a procedural device used in vivo (within the body) during a medical procedure.
- Device Description: The description details a physical device (sheath, dilator, valves, etc.) used for accessing blood vessels.
- Anatomical Site: The device is used in the "peripheral vasculature," which is a part of the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are typically used to perform tests on biological samples to gain information about a patient's health status. The Intri24 Sheath is a tool used to facilitate a medical procedure, not to perform a diagnostic test on a sample.
N/A
Intended Use / Indications for 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.
Product codes
DYB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vasculature, peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing: In accordance with the Design Failure Modes and Effects Analysis, verification and validation testing were identified to support the substantial equivalence of the Intri24 Sheath. This testing demonstrated compliance 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 accordance with 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 of substantial equivalence. Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
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. |
| 6001 Oak Canyon, Suite 100 | |
| Irvine, CA 92618 | |
| 877-923-4747 | |
| Contact person | Kit Cariquitan |
| Vice President, Regulatory Affairs & Quality Assurance | |
| Name of Device | Intri24 Sheath |
| Common name | Introducer Sheath |
| Regulation name | Catheter Introducer |
| Classification | |
| number | 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 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. | |
| Indications for 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. | |
| Comparison of | |
| Technological | |
| Characteristics with | |
| the Predicate Device | The indications for use and principles of operation of the Intri24 Sheath |
| and the predicate device are substantially the same. Both devices act | |
| as conduit for the insertion and removal of endovascular devices. The | |
| design and materials of construction of both devices is 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 in guidewire | |
| compatible) with a tapered tip to aid in dilation of the target vessel when | |
| inserting the sheath. |
The Intri24 Sheath contains a user-actuated hemostasis valve identical
to that used on the ClotTriever catheter and sheath (K180329). The
hemostasis valve on the Intri24 Sheath allows for inserting or
withdrawing endovascular devices through the sheath. The user
actuated hemostasis valve is operated by spring-loaded push buttons.
The W.L. Gore DrySeal hemostasis valve contains an inflatable ring
which closes when saline is injected and opens when saline is
withdrawn from the ring. |
| Summary of
substantial
equivalence | The Intri24 Sheath's design, materials, mechanism of action, and
performance specifications are substantially equivalent to the predicate
device.
Non-Clinical Testing
In accordance with the Design Failure Modes and Effects Analysis,
verification and validation testing were identified to support the
substantial equivalence of the Intri24 Sheath. This testing demonstrated
compliance 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 accordance
with 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 of
substantial equivalence. | |
| Test results demonstrated that all acceptance criteria were met;
therefore, the device conforms to established product specifications. | |
| Conclusion | |
| testing demonstrated that the Intri24
Non-clinical
Sheath is
substantially equivalent to the W.L. Gore DrySeal Sheath with
Hydrophilic Coating with respect to design, materials, function, and
intended use. | |
| | |
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