(243 days)
No
The device description and performance studies focus on the mechanical components and physical properties of the occlusion system, with no mention of AI or ML.
Yes.
The device is used for arterial and venous embolization, which is a medical procedure to block blood flow, thus making it a therapeutic intervention.
No
The device is an embolization system used for treatment by occluding blood vessels, not for diagnosis.
No
The device description clearly outlines multiple hardware components including an implant, delivery catheter, guide catheter, and dilator. It is a physical medical device used for embolization.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "arterial and venous embolization in the peripheral vasculature." This describes a therapeutic procedure performed within the body to block blood vessels.
- Device Description: The device is a system for delivering an implant (coil scaffold with a membrane) into blood vessels. This is a medical device used for treatment, not for analyzing samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory tests.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a therapeutic device used for embolization.
N/A
Intended Use / Indications for Use
The ArtVentive Endoluminal Occlusion System - EOS-X is indicated for arterial and venous embolization in the peripheral vasculature.
Product codes
KRD
Device Description
The ArtVentive Endoluminal Occlusion System (EOS-X) has been developed for arterial and venous embolization in the peripheral vasculature. The system consists of three major components: a preloaded implant, the delivery catheter, and the guide catheter with dilator. The EOS-X is intended for single use only.
Like the predicate ArtVentive Endoluminal Occlusion System (EOS)™, the ArtVentive Endoluminal Occlusion System (EOS-X) is comprised of an implant made of a Nitinol coil scaffold with an ePTFE occlusion membrane and is designed with radial force sufficient to provide stiffness and strength against the vessel wall and minimize post-deployment migration. The delivery system is made up of a delivery catheter and the guide catheter with dilator. The implant delivery catheter contains one implant loaded on the distal end and a deployment handle on the proximal end connected by the shaft. The delivery catheter has a low profile and is flexible to allow for trackability and pushability. The implant itself and the catheter's distal end are visible under fluoroscopy.
The guide catheter is a braided shaft with a stiff proximal section and a more flexible distal section to enable tracking through tortuous peripheral vasculature. A radiopaque marker on the distal end of the catheter is visible under fluoroscopy. The guide catheter is tapered to fit over the dilator. The dilator fits inside the guide catheter exiting out through the distal end. The dilator also has a tapered end for ease of advancement into the blood vessel. The guidewire and dilator are removed from the guide catheter once it is in position for delivery of the implant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
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)
Engineering Performance Studies conducted demonstrated that the ArtVentive Endoluminal Occlusion System (EOS-X) which adds a larger 16mm size of delivery catheter/implant for use with the 6F size guide catheter as well as the minor design modifications made to the 5mm and 8mm and 11mm sizes as compared to its predicate performed as intended. The following testing was repeated for the additional sizes of the device: dimensional and functional design verification/validation, MRI compatibility, corrosion, and radial strength. The design verification and validation testing were also repeated as necessary for the design modifications to the previously cleared 5mm and 8mm delivery catheter/implant and the 6 Fr guide catheter.
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
§ 870.3300 Vascular embolization device.
(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 1, 2022
ArtVentive Medical Group, Inc. Anil Bhalani RA/OA Consultant 1797 Playa Vista San Marcos, California 92708
Re: K212057
Trade/Device Name: Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: January 26, 2022 Received: January 31, 2022
Dear Anil Bhalani:
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,
Misti Malone 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
2
Indications for Use
510(k) Number (if known) K212057
Device Name
Endoluminal Occlusion System (EOS-X)
Indications for Use (Describe)
The ArtVentive Endoluminal Occlusion System - EOS-X is indicated for arterial and venous embolization 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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3
510(k) SUMMARY
ArtVentive Endoluminal Occlusion System (EOS-X)™
| 510(k) Number | K212057 |
|---|---|
| Applicant: | ArtVentive Medical Group, Inc. |
| 1797 Playa Vista | |
| San Marcos, CA 92708 | |
| Company Contact: | Anil Bhalani |
| RA/QA Consultant | |
| Phone: 949-596-9001 | |
| Email: anilbhalani@artventivemedical.com | |
| Date Summary Prepared: | June 25, 2021 |
| Device Trade Name: | ArtVentive Endoluminal Occlusion System (EOS-X)TM |
| Common/Classification Name: | Vascular embolization device, Class II |
| Regulation Number/Name: | 21 CFR §870.3300 - Vascular embolization device |
| Review Panel: | Cardiovascular |
| Product Code: | KRD |
| Predicate Devices: | Endoluminal Occlusion System (EOS)TM |
| (K150402) |
Device Description:
The ArtVentive Endoluminal Occlusion System (EOS-X) has been developed for arterial and venous embolization in the peripheral vasculature. The system consists of three major components: a preloaded implant, the delivery catheter, and the guide catheter with dilator. The EOS-X is intended for single use only.
Like the predicate ArtVentive Endoluminal Occlusion System (EOS)™, the ArtVentive Endoluminal Occlusion System (EOS-X) is comprised of an implant made of a Nitinol coil scaffold with an ePTFE occlusion membrane and is designed with radial force sufficient to provide stiffness and strength against the vessel wall and minimize post-deployment migration. The delivery system is made up of a delivery catheter and the guide catheter with dilator. The implant delivery catheter contains one implant loaded on the distal end and a deployment handle on the proximal end connected by the shaft. The delivery catheter has a low profile and is flexible to allow for trackability and pushability. The implant itself and the catheter's distal end are visible under fluoroscopy.
4
The guide catheter is a braided shaft with a stiff proximal section and a more flexible distal section to enable tracking through tortuous peripheral vasculature. A radiopaque marker on the distal end of the catheter is visible under fluoroscopy. The guide catheter is tapered to fit over the dilator. The dilator fits inside the guide catheter exiting out through the distal end. The dilator also has a tapered end for ease of advancement into the blood vessel. The guidewire and dilator are removed from the guide catheter once it is in position for delivery of the implant.
| Manufacturer/ Device | ArtVentive Endoluminal
Occlusion System (EOS-X) | ArtVentive Endoluminal
Occlusion System (EOS) |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K212057 | K150402 |
| Application / Product Code | 21 CFR 870.3300 (KRD) | 21 CFR 870.3300 (KRD) |
| FDA Classification | Class II | Class II |
| Technological
Characteristics | | |
| Intended Use | The ArtVentive Endoluminal
Occlusion System (EOS-X)TM
is intended for arterial and
venous embolization in the
peripheral vasculature. | The ArtVentive Endoluminal
Occlusion System (EOS)TM is
intended for arterial and
venous embolization in the
peripheral vasculature. |
| Design Features | Flexible, low profile device
for immediate, acute occlusion
of the target vessel. The
device incorporates an ePTFE
cover. Retrievable; may be
removed during deployment
and re-positioned. Two-stage
deployment handle on the
proximal end. The catheter has
a stiff proximal section for
pushability and a flexible
distal section for trackability.
The deployment handle has a
side port to accommodate
syringe attachment to flush the
catheter of air and to pre-
expand the ePTFE membrane
before deploying the implant. | Flexible, low profile device
for immediate, acute occlusion
of the target vessel. The
device incorporates an ePTFE
cover. Retrievable; may be
removed during deployment
and re-positioned. Two-stage
deployment handle on the
proximal end. The catheter has
a stiff proximal section for
pushability and a flexible
distal section for trackability.
The deployment handle has a
side port to accommodate
syringe attachment to flush the
catheter of air and to pre-
expand the ePTFE membrane
before deploying the implant. |
| Implant Material | Nitinol coil with an ePTFE
polymeric cover | Nitinol coil with an ePTFE
polymeric cover |
| Detachment | Mechanical in nature | Mechanical in nature |
| Implant Size | 5mm, 8mm, 11mm, 16mm | 5mm, 8mm, 11mm |
| Treatment Method | Permanent Implant | Permanent Implant |
| How Applied | Via delivery catheter through
a guide catheter to target
vessel | Via delivery catheter through
a guide catheter to target
vessel |
Comparison to Predicate Device:
5
Implant and Guide Catheter Selection Matrix:
| Implant Size | EOS or EOS-X | Reference Vessel
Diameter | Reference ArtVentive Guide
Catheter Compatibility |
|--------------|--------------|------------------------------|------------------------------------------------------|
| 5mm | EOS-X | 2.0mm - 5mm | 4F or larger |
| 8mm | EOS-X | 4.5mm - 8mm | 5F or larger |
| 11mm | EOS-X | 7.5mm - 11mm | 6F or larger |
| 16mm | EOS-X | 10.5mm - 16mm | 6F or larger |
| 5mm | EOS | 3.0 mm - 5.0mm | 6F or larger |
| 8mm | EOS | 4.5mm - 8mm | 6F or larger |
| 11mm | EOS | 7.5mm - 11mm | 7.5F or larger |
Indications for Use:
The ArtVentive Endoluminal Occlusion System (EOS-X) is indicated for arterial and venous embolization in the peripheral vasculature.
Contraindications:
· Implantation in proximity to high motility (locomotor) muscles
Intended Use:
The ArtVentive Endoluminal Occlusion System (EOS-X) has been developed for arterial and venous embolization in the peripheral vasculature. The device is provided sterile and is intended for a single use only. It is intended to be placed in the peripheral vasculature using a guide catheter of appropriate size.
Technological Characteristics:
The Fundamental Scientific Technology of the previously cleared predicate device, The ArtVentive Endoluminal Occlusion System (EOS) via K992189 is substantially equivalent to The ArtVentive Endoluminal Occlusion System (EOS-X).
Performance Data Summary:
Engineering Performance Studies conducted demonstrated that the ArtVentive Endoluminal Occlusion System (EOS-X) which adds a larger16mm size of delivery catheter/implant for use with the 6F size guide catheter as well as the minor design modifications made to the 5mm and 8mm and 11mm sizes as compared to its predicate performed as intended. The following testing was repeated for the additional sizes of the device: dimensional and functional design verification/validation, MRI compatibility, corrosion, and radial strength. The design verification and validation testing were also repeated as necessary for the design modifications to the previously cleared 5mm and 8mm delivery catheter/implant and the 6 Fr guide catheter. The review of the technological characteristics, indications for use, and verification and validation information provided in the 510(k) Premarket Notification demonstrates that the ArtVentive Medical Group Endoluminal Occlusion System-EOS-X is substantially equivalent to its predicate device.
6
Substantial Equivalence:
The ArtVentive Endoluminal Occlusion System (EOS-X) is substantially equivalent to its predicate device, the ArtVentive Endoluminal Occlusion System (EOS) and introduces no new safety and effectiveness issues when used as instructed by accompanying labels and labelling.
The substantial equivalence is based on the information provided in this 510(k) Premarket Notification which demonstrates that the EOS-X and EOS have equivalent technological characteristics, mechanism of action, intended use and physical characteristics. The design modifications made to the EOS-X device in sizes 5mm, 8mm and 11mm delivery catheter/ implant and associated guide catheters are also substantially equivalent to the predicate device when used according to its intended use. The larger size 16mm delivery catheter/implant is also similar to the other smaller models of EOS and EOS-X in technological characteristics, mechanism of action, intended use and physical characteristics. The equivalence is based on repeating the applicable design verification and validation testing.
Conclusion:
Information in this 510(k) submission demonstrates that the ArtVentive Endoluminal Occlusion System (EOS-X) is substantially equivalent to its predicate device.