(32 days)
No
The document describes a mechanical device (balloon thrombectomy sheath) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended for the non-surgical aspiration of emboli and thrombi from blood vessels, which is a therapeutic intervention for conditions like thrombosis or embolism.
No
The device is described as a thrombectomy sheath used for aspiration, infusion, and guiding catheters, which are therapeutic and interventional procedures, not diagnostic ones.
No
The device description clearly outlines physical components such as a sheath, balloon, syringes, and a stopcock, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body.
- Device Description and Intended Use: The Artix BG balloon thrombectomy sheath is a device used within the body (in the peripheral vasculature) for procedures like aspiration of thrombi, infusion/aspiration of fluids, and guiding catheters. It is a surgical/interventional device, not a diagnostic test performed on a sample.
The description clearly indicates it's a tool used directly in the patient's blood vessels for therapeutic and procedural purposes.
N/A
Intended Use / Indications for Use
The Artix BG balloon thrombectomy sheath is indicated for:
- · The non-surgical aspiration of emboli and thrombi from blood vessels.
- · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
- · Use as a conduit for retrieval devices.
- · Use in facilitating the insertion and quidance of an intravascular catheter into a selected blood vessel. The balloon provides temporary vascular occlusion during these and other angiographic procedures.
The Artix BG balloon thrombectomy sheath is intended for use in the peripheral vasculature.
Product codes
QEW, DQY
Device Description
The Artix BG is a single-use, over-the-wire system designed to aspirate thrombi and emboli from the peripheral vasculature, facilitate the insertion and guidance of an intravascular catheter into selected peripheral blood vessels, and act as a conduit for retrieval devices. A compliant balloon mounted at the sheath's distal tip provides temporary vascular occlusion during angiographic and interventional procedures. The Artix BG is also capable of infusion/aspiration of fluids into or from a selected vessel. The Artix BG is packaged with the following components: Artix BG balloon thrombectomy sheath (8 Fr, 65 cm or 105 cm) 8 Fr Introducer Dilator (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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing: As there were no proposed design changes, previous performance test results that demonstrated that all acceptance criteria were met continue to apply; therefore, the device conforms to established product specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 2, 2023
Inari Medical Ellen Nguyen Regulatory Affairs Specialist 6001 Oak Canyon Suite 100 Irvine, California 92618
Re: K230912
Trade/Device Name: Artix BG Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, DQY Dated: March 31, 2023 Received: March 31, 2023
Dear Ellen Nguyen:
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
1
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 (OS) 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,
Gregory W. Digitally signed by
Gregory W. Gregory W. O'connell -S O'connell -S 08:47:10 -04'00'
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
Submission Number (if known)
Device Name
Artix BG
Indications for Use (Describe)
The Artix BG balloon thrombectomy sheath is indicated for:
- · The non-surgical aspiration of emboli and thrombi from blood vessels.
- · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
- · Use as a conduit for retrieval devices.
- · Use in facilitating the insertion and quidance of an intravascular catheter into a selected blood vessel. The balloon provides temporary vascular occlusion during these and other angiographic procedures.
The Artix BG balloon thrombectomy 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 2
510(K) SUMMARY
| Date prepared | March 31, 2023 | |
|---|---|---|
| Name | Inari Medical, Inc. | |
| 6001 Oak Canyon, Suite 100 | ||
| Irvine, CA 92618 | ||
| 949.600.8433 | ||
| Contact person | Ellen Nguyen | |
| Regulatory Affairs Specialist | ||
| Name of Device | Artix BG | |
| Common name | Embolectomy catheter | |
| Regulation name | Embolectomy catheter | |
| Classification number | 21 CFR 870.5150 | |
| Product code | QEW | |
| Secondary product code | DQY | |
| Regulatory class | II | |
| Predicate device | Inari Medical, Artix BG (K223000) | |
| This device has not been subject to a design-related recall. | ||
| Description | The Artix BG is a single-use, over-the-wire system designed to aspirate thrombi | |
| and emboli from the peripheral vasculature, facilitate the insertion and guidance of | ||
| an intravascular catheter into selected peripheral blood vessels, and act as a conduit | ||
| for retrieval devices. A compliant balloon mounted at the sheath's distal tip | ||
| provides temporary vascular occlusion during angiographic and interventional | ||
| procedures. The Artix BG is also capable of infusion/aspiration of fluids into or | ||
| from a selected vessel. The Artix BG is packaged with the following components: | ||
| Artix BG balloon thrombectomy sheath (8 Fr, 65 cm or 105 cm) 8 Fr Introducer Dilator (0.014" and 0.035" guidewire compatibility) Balloon Inflation Syringe, 1 mL Large Bore Syringe, 30 mL 3-way Stopcock | ||
| Indications for Use | The Artix BG balloon thrombectomy sheath is indicated for: | |
| The non-surgical aspiration of emboli and thrombi from blood vessels. Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. Use as a conduit for retrieval devices. 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 BG balloon thrombectomy sheath is intended for use in the peripheral | ||
| vasculature. | ||
| Device Modifications | The proposed modification to the Artix BG is the addition of two alternate suppliers | |
| for the device's PTFE liner. | ||
| Comparison of | ||
| Technological | ||
| Characteristics with | ||
| the Predicate Device | The proposed device and predicate device have the same design and materials of | |
| construction. The modification does not change the basic design, the indications for | ||
| use, or the principles of operation from the predicate device. | ||
| Summary of | ||
| substantial equivalence | There is no change of intended use, design, fundamental scientific technology, or | |
| principles of operation between the proposed device and predicate device. The | ||
| Artix BG has the same indication for use as the predicate device, K223000. | ||
| Biocompatibility | ||
| The following biocompatibility tests were completed for the subject device: | ||
| Cytotoxicity ● | Sensitization ● | |
| Intracutaneous Reactivity ● | Acute Systemic Toxicity ● | |
| Material-Mediated ● | ||
| Pyrogenicity | Hemocompatibility ● | |
| (Hemolysis) | ||
| The passing results demonstrate that the subject device and accessories meet | ||
| biological safety requirements per ISO 10993-1. | ||
| Sterilization | ||
| The subject device, including its accessories, is sterilized using EtO to achieve a | ||
| sterility assurance level (SAL) of 10-6 using a validated sterilization process in | ||
| accordance with the principles of ISO 11135:2014/Amd 1:2018 and AAMI TIR | ||
| 28:2016. | ||
| Non-Clinical Testing | ||
| As there were no proposed design changes, previous performance test results that | ||
| demonstrated that all acceptance criteria were met continue to apply; therefore, the | ||
| device conforms to established product specifications. | ||
| Neither animal testing nor clinical testing were required for the determination of | ||
| substantial equivalence. | ||
| Conclusion | ||
| The Artix BG has the same intended use/indications for use and principles of | ||
| operation as the predicate. The testing provided supports the Artix BG's substantial | ||
| equivalence to the predicate device. |
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