(17 days)
No
The document describes a mechanical device (balloon guiding sheath) and its components. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML. The performance studies focus on mechanical properties and equivalence to a predicate device.
No
The device is used to facilitate the insertion and guidance of catheters and retrieval devices, and to provide temporary vascular occlusion. It is an accessory device rather than a primary therapeutic intervention.
No
The device is described as a guiding sheath and a conduit for retrieval devices, with its primary function being to facilitate the insertion and guidance of other catheters or retrieve devices, and to provide temporary vascular occlusion. It is not intended for diagnosing medical conditions.
No
The device description clearly outlines physical components such as a sheath, balloon, dilators, and syringes, indicating it is a hardware-based medical device.
Based on the provided information, the Artix Balloon Guiding Sheath is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) to facilitate the insertion and guidance of catheters and provide temporary vascular occlusion during angiographic procedures. IVD devices are used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a physical device designed to be inserted into blood vessels, not a reagent, instrument, or system for analyzing biological samples.
- Anatomical Site: The device is intended for use in the peripheral vasculature, which is an in vivo application.
- Performance Studies: The performance studies described are non-clinical tests related to the physical and functional characteristics of the device for in vivo use, not studies evaluating the performance of a diagnostic test on biological samples.
Therefore, the Artix Balloon Guiding Sheath is a medical device used for interventional procedures within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Artix Balloon Guiding Sheath is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Artix Balloon Guiding Sheath is also indicated for use as a conduit for retrieval devices.
The Artix Balloon Guiding Sheath is intended for use in the peripheral vasculature.
Product codes
DQY
Device Description
The Artix Balloon Guiding Sheath is a single-use, over-the-wire system designed to facilitate the insertion and guidance of an intravascular catheter into a selected peripheral blood vessel and act as a conduit for retrieval devices. A compliant balloon mounted at the sheath's distal tip provides temporary vascular occlusion during angiographic procedures. The Artix Balloon Guiding Sheath is packaged with the following components:
Artix Balloon Guiding Sheath (8 Fr, 65 cm or 105 cm)
Two 8 Fr Introducer Dilators (0.014" and 0.035" guidewire compatibility)
Balloon Inflation Syringe, 1 mL
Large Bore Syringe, 30 mL
3-way Stopcock
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
Indicated Patient Age Range
Adults
Intended User / Care Setting
Not Found
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
Non-Clinical Testing: A series of verification and validation tests were performed based on a Design Failure Modes and Effects Analysis. These included: Pouch Seal Peel Test, Pouch Seal Inspection and Pouch Dye Penetration, Packaging Retention, Visual and Dimensional Inspections Sheath, Dimensional Inspections Sheath Inner Diameter, Visual and Dimensional Inspections - Dilator, Dimensional Inspections Dilator Outer Diameter, Guidewire Compatibility, Dilator, Visual Sheath and Dilator, Dimensional Inspections Sheath Working Length, Simulated Use Cycling, Cap Locking, Device Retrieval Testing, Device Priming, Air Leak Testing, Syringe Pullback, Fluid Leak Testing, Sheath, Fluid Leak Testing, Dilator, Air Leak Testing, Dilator Removal, 30 mL Large Bore Syringe Vacuum, Balloon Fatigue Test, Sheath and Dilator Kink Radius, Dye Staining, Post-Use, Vacuum Testing, Dilator Hub to Cap Tensile, 30 mL Large Bore Syringe, Tip Adapter to Barrel Tensile, Unlocking Cap, Torque, Insertion Force, Dilator Through Sheath, Flushing Side Port to Hemostasis Valve Assembly and Inflation Hub . Tensile, Hemostasis Valve Assembly to Sheath Shaft and Dilator Tensile, Engaged Housing, Cap Axial Detachment, Balloon Diameter, Inflated, Barbed Luer to Inflation Hub Torque, Balloon Burst Volume, Retraction Force, Dilator from Sheath, Lubricity, Post-Use, Particulate Matter Determination, Torque. Sheath and Dilator, Balloon Inflation Volume to Balloon Diameter, Balloon Deflation Time. Sheath Compatibility with Intravascular Catheter and Diagnostic Catheter in Model, Sheath Kink to Failure, Sheath Torque to Failure, Sheath Tip Tensile, Sheath Burst, Manual Syringe Injection Flow Rate and Max Pressure.
Key results: Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(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: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 11, 2022
Inari Medical % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K221846
Trade/Device Name: Artix Ballon Guiding Sheath Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DOY Dated: June 23, 2022 Received: June 24, 2022
Dear Prithul Bom:
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
1
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,
For Misti Malone Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221846
Device Name Artix Balloon Guiding Sheath
Indications for Use (Describe)
The Artix Balloon Guiding Sheath is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Artix Balloon Guiding Sheath is also indicated for use as a conduit for retrieval devices.
The Artix Balloon Guiding Sheath is intended for use in the peripheral vasculature.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| 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 | June 9, 2022 |
|---|---|
| Name | Inari Medical, Inc. |
| 6001 Oak Canyon, Suite 100 | |
| Irvine, CA 92618 | |
| 877.923.4747 | |
| Contact person | Ellen Nguyen |
| Regulatory Affairs Specialist | |
| Trade name | Artix Balloon Guiding Sheath |
| Common name | Balloon guiding sheath |
| Regulation name | Percutaneous catheter |
| Classification number | 21 CFR 870.1250 |
| Product code | DQY |
| Regulatory class | II |
| Predicate device | Concentric Medical, 8F FlowGate2 Balloon Guide Catheter (K153729) |
| Reference device | Medtronic Vascular, Inc., Sentrant Introducer Sheath with Hydrophilic Coating (K171866) |
| Description | The Artix Balloon Guiding Sheath is a single-use, over-the-wire system designed to |
| facilitate the insertion and guidance of an intravascular catheter into a selected | |
| peripheral blood vessel and act as a conduit for retrieval devices. A compliant | |
| balloon mounted at the sheath's distal tip provides temporary vascular occlusion | |
| during angiographic procedures. The Artix Balloon Guiding Sheath is packaged with | |
| the following components: | |
| Artix Balloon Guiding Sheath (8 Fr, 65 cm or 105 cm)Two 8 Fr Introducer Dilators (0.014" and 0.035" guidewire compatibility)Balloon Inflation Syringe, 1 mLLarge Bore Syringe, 30 mL3-way Stopcock | |
| Indications for Use | The Artix Balloon Guiding Sheath is indicated for use in facilitating the insertion |
| and guidance of an intravascular catheter into a selected blood vessel. The balloon | |
| provides temporary vascular occlusion during these and other angiographic | |
| procedures. The Artix Balloon Guiding Sheath is also indicated for use as a conduit | |
| for retrieval devices. | |
| The Artix Balloon Guiding Sheath is intended for use in the peripheral vasculature. |
4
Summary of substantial equivalence
The Artix Balloon Guiding Sheath and predicate device have the same indications for use statement: both are indicated for vascular access, facilitating the insertion and guidance of intravascular devices into selected blood vessels in the peripheral vasculature, providing temporary vessel occlusion during angiographic procedures, and to act as a conduit for retrieval devices. Unlike the predicate device, the Artix Balloon Guiding Sheath is not indicated for use in the neurovasculature.
A tabular comparison of specific technological characteristics between the predicate and subject device is provided below:
| Feature | Subject Device | 8F FlowGate2 Balloon
Guide Catheter - Predicate
(K153729) |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Inari Medical | Concentric Medical |
| Product code | DQY | DQY |
| Intended
use/Indications for
use | The Artix Balloon Guiding
Sheath is indicated for use in
facilitating the insertion and
guidance of an intravascular
catheter into a selected blood
vessel. The balloon provides
temporary vascular occlusion
during these and other
angiographic procedures. The
Artix Balloon Guiding Sheath is
also indicated for use as a
conduit for retrieval devices.
The Artix Balloon Guiding
Sheath is intended for use in the
peripheral vasculature. | FlowGate2 Balloon Guide
Catheters are indicated for
use in facilitating the
insertion and guidance of an
intravascular device into a
selected blood vessel in the
peripheral and neurovascular
systems. The balloon
provides temporary vascular
occlusion during these and
other angiographic
procedures. The Balloon
Guide Catheter is also
indicated for use as a conduit
for retrieval devices. |
| Device description | The Artix Balloon Guiding
Sheath is comprised of a single
through lumen shaft with four
(4) embedded lumens for
balloon inflation and deflation, a
proximal integrated hemostasis
valve to minimize blood loss, a
stopcock with flush port, and a
balloon port. To assist with
insertion of the sheath into the
vasculature, a hydrophilic
coating covers a portion of the
distal sheath shaft. The distal tip
of the sheath shaft contains two
(2) radiopaque marker bands to
aid with angiographic
visualization: The distal marker
indicates the location of the
sheath's tip, while the proximal
marker band marks the location
of a compliant balloon mounted | The FlowGate2 Balloon
Guide Catheters are coaxial-lumen, braid-reinforced,
variable stiffness catheters
designed for use in
facilitating the insertion and
guidance of an intravascular
catheter into a selected blood
vessel in the peripheral and
neurovascular systems. A
radiopaque marker is
included on the distal end for
angiographic visualization. A
compliant balloon is
mounted on the distal end to
provide temporary vascular
occlusion during
angiographic procedures. A
bifurcated luer hub on the
proximal end allows
attachments for flushing,
inflation, and aspiration. |
| Feature | Subject Device | 8F FlowGate2 Balloon Guide Catheter - Predicate (K153729) |
| | at the distal end. The balloon provides temporary vascular occlusion during angiographic procedures. | Balloon Guide Catheter dimensions and maximum recommended balloon inflation volume are indicated on product label. |
| Principles of operation | After the target vessel is accessed and dilated, the Artix Balloon Guiding Sheath is inserted into the vessel over a guidewire. Once the Artix Balloon Guiding Sheath is in position, the dilator is removed, and all compatible catheter devices can be inserted through the Artix Balloon Guiding Sheath for access into the peripheral vasculature. The sheath's balloon can also be inflated using a 1 mL syringe to provide flow occlusion of the vessel during the procedure. | After the target vessel is accessed and dilated, the 8F FlowGate2 Balloon Guide Catheter is inserted into the vessel. The dilator can then be removed to allow compatible working devices to be inserted through the catheter. The balloon can also be inflated to provide flow occlusion of the vessel. |
| Intended patient population | Adults undergoing interventional procedures | Adults undergoing interventional procedures |
| Target vessel | Peripheral vasculature | Peripheral and neurovasculature |
| Placement duration |