(345 days)
Not Found
No
The device description focuses on the mechanical components and materials of the occlusion system and delivery catheter. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies described are bench and animal studies, not studies evaluating algorithmic performance.
No.
The device is used to occlude (block) blood vessels, which is an interventional procedure, not necessarily a therapeutic one in the sense of treating a disease or disorder through non-invasive means. While the occlusion might be part of a broader treatment strategy, the device itself performs a mechanical function.
No
The device is described as an "Endoluminal Occlusion System" intended for "percutaneous occlusion of the peripheral arterial and venous vasculature," which indicates a therapeutic or interventional function, not a diagnostic one.
No
The device description clearly outlines physical components including an implant, implant carrier catheter, and guide sheath, which are hardware. The summary also mentions bench studies involving physical testing like dimensional verification, sterilization, and mechanical properties.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "percutaneous occlusion of the peripheral arterial and venous vasculature." This describes a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a physical implant and delivery system designed to be placed within blood vessels.
- Mechanism of Action: The device works by physically blocking blood flow within a vessel.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The ArtVentive Medical Group Endoluminal Occlusion System (AVMG EOS) is indicated for the percutaneous occlusion of the peripheral arterial and venous vasculature.
Product codes (comma separated list FDA assigned to the subject device)
KRD
Device Description
The ArtVentive Medical Group Endoluminal Occlusion System™ (AVMG EOS™) has been developed for arterial and venous embolizations in the peripheral vasculature. The system consists of three major components: a preloaded implant, the implant carrier catheter, and the guide sheath with removable core. The AVMG EOS™ is intended for single use only.
The implant is 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 the implant carrier catheter and the guide sheath with removable core. The implant carrier 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 catheter's distal end are visible under fluoroscopy.
The guide sheath 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 sheath is visible under fluoroscopy. The tip of the sheath is tapered to fit over the removable core. The removable core fits inside the guide sheath, exiting out through the distal end. The removable core also has a tapered end for ease of advancement into the blood vessel. The guidewire and core are removed from the guide sheath 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 arterial and venous 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)
Bench studies indicate that the ArtVentive Medical Group's EOS™ device performs as intended. The following testing was performed: dimensional design verification/validation, sterilization validation, transit and package integrity testing, GLP chronic animal safety testing, MRI compatibility, corrosion, radial strength and biocompatibility testing. The performance of the ArtVentive EOS demonstrates that the product is substantially equivalent to the performance of the predicate devices. The equivalence was shown through component materials and specifications, performance, biocompatibility testing, and sterilization validation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles, with the head tilted upwards.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 3, 2014
ArtVentive Medical Group, Inc. % Roberta Hines Northwest Clinical Research Group, Inc. 24125 85th Avenue SE Woodinville, WA 98072
Re: K133924
Trade/Device Name: Endoluminal Occlusion System (EOS)TM Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: October 22, 2014 Received: October 24, 2014
Dear Roberta Hines:
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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kenneth J. Cavanaugh -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K133924
Device Name Endoluminal Occlusion System (EOS)™
Indications for Use (Describe)
The ArtVentive Medical Group Endoluminal Occlusion System (AVMG EOS) is indicated for the percutaneous occlusion of the peripheral arterial and venous 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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Image /page/3/Picture/0 description: The image shows the logo for ArtVentive Medical Group, Inc. The logo features a stylized "AV" in blue, with the letters connected by a curved line. Below the symbol, the word "ArtVentive" is written in a sans-serif font, with the words "MEDICAL GROUP, INC" in a smaller font size below it. The logo is clean and modern, with a focus on the company's name and medical focus.
K133924
510(k) Summar
In accordance with 21 CFR 807.92 (Summary):
A summary of the information regarding the safety and effectiveness of the ArtVentive Medical Group Endoluminal Occlusion System (AVMG EOS™), as required by the Safe Medical Device Amendments of 1990, is provided as follows:
| 510(k) Summary for the | |
|---|---|
| ArtVentive Medical Group Endoluminal Occlusion System™ | |
| 1. Applicant: | ArtVentive Medical Group, Inc. |
| 2. Address: | ArtVentive Medical Group, Inc. |
| 2766 Gateway Road | |
| Carlsbad, CA 92009 | |
| 3. Sponsor Contact Person: | Leon Rudakov, PhD., President and CTO |
| 4. Telephone: | |
| E-mail: | 650-465-5259 |
| leonrudakov@artventivemedical.com | |
| 5. 510(k) Summary Preparation | |
| Date: | December 2, 2014 |
| 6. Device Trade Name: | Endoluminal Occlusion System (EOS)™ |
| 7. Common Name: | Vascular Embolization Device |
| 8. Classification Name: | Device Embolization, Vascular |
| (21 CFR 870.3300, Product Code: KRD) | |
| 9. Legally Marketed Predicate | |
| Devices: | AGA Medical/Amplatzer® Vascular Plug II (K071125) |
| AGA Medical/Amplatzer® Vascular Plug 4 (K113658) | |
| Reverse Medical MVP™ Micro Vascular Plug System (K123803) |
10. Description of the ArtVentive Medical Group - Endoluminal Occlusion System (EOS™):
The ArtVentive Medical Group Endoluminal Occlusion System™ (AVMG EOS™) has been developed for arterial and venous embolizations in the peripheral vasculature. The system consists of three major components: a preloaded implant, the implant carrier catheter, and the guide sheath with removable core. The AVMG EOS™ is intended for single use only.
The implant is 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 the implant carrier catheter and the guide sheath with removable core. The implant carrier 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 catheter's distal end are visible under fluoroscopy.
4
The guide sheath 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 sheath is visible under fluoroscopy. The tip of the sheath is tapered to fit over the removable core. The removable core fits inside the guide sheath, exiting out through the distal end. The removable core also has a tapered end for ease of advancement into the blood vessel. The guidewire and core are removed from the guide sheath once it is in position for delivery of the implant.
11. Comparison to Predicate Devices:
| Manufacturer /
Device | ArtVentive Medical Group,
Inc./EOS | AGA Medical / Amplatzer®
Vascular Plug II | AGA Medical / Amplatzer®
Vascular Plug 4 | Reverse Medical MVP™ Micro
Vascular Plug System |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K133924 | K071125 | K113658 | K123803 |
| Application / Product
Code | 21 CFR 870.3300 (KRD) | 21 CFR 870.3300 (KRD) | 21 CFR 870.3300 (KRD) | 21 CFR 870.3300 (KRD) |
| FDA Classification | Class II | Class II | Class II | Class II |
| Technological
Characteristics | | | | |
| Intended Use | The ArtVentive EOS™ is intended
for arterial and venous
embolizations in the peripheral
vasculature. | The AMPLATZER® Vascular
Plug II is indicated for arterial
and venous embolizations in
the peripheral vasculature. | The AMPLATZER Vascular Plug
4 is indicated for arterial and
venous embolizations in the
peripheral vasculature. | The Reverse Medical MVP™ Micro
Vascular Plug System is intended for
use to obstruct or reduce the rate of
blood flow 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. | Unique multi-segmented,
multi-layered design
significantly reduces occlusion
time for transcatheter
embolization procedures. The
three adjustable lobes of the
AMPLATZER Vascular Plug II
are designed for enhanced
conformability to vessel
landing zones. May be
repositioned. Multiple
vascular plugs may be used to
occlude vessel. | The AMPLATZER® Vascular
Plug 4 is delivered through a
0.038 diagnostic catheter.
The flexible mesh and the
floppy distal section of the
delivery wire enable the
device to travel through
tortuous anatomy with ease
while the multi-layered,
double-lobed design provides
rapid embolization. May be
repositioned. | The MVP Device is ovoid-shape,
comprised of nitinol and secured at
both ends with platinum marker
bands. The device incorporates a
PTFE partial cover. The proximal
marker band attaches to a wire that
pushes the device through a
commercially available
microcatheter to the intended
treatment site. The "delivery wire"
detaches from the MVP Device by
electrolytic means after deployment
with the Reverse Medical
Detachment System. Full
resheathability enables precise
delivery.
The MVP System is packaged as a
single unit with the MVP Device,
introducer sheath and detachable
delivery wire. The system is provided
sterile, non-pyrogenic, and is
intended for single use only. |
| Material | Nitinol coil with an ePTFE
polymeric cover | Nitinol mesh | Nitinol mesh with a
radiopaque marker band | Nitinol coil with an ePTFE polymeric
partial cover and platinum marker
bands |
| Detachment | Mechanical in nature | Mechanical in nature | Mechanical in nature | Electrolytic means of deployment |
5
| Manufacturer /
Device | ArtVentive Medical Group,
Inc./EOS | AGA Medical / Amplatzer®
Vascular Plug II | AGA Medical / Amplatzer®
Vascular Plug 4 | Reverse Medical MVPT™ Micro
Vascular Plug System | | | | |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|--------------------------------------------------------------------------------|----------------------------------------------------------------------------|-------------------------------------------|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Sizes | Diameter
(mm)
5
8
5mm diameter for target vessel
diameter
3.0mm - 5.0mm
8mm diameter for target vessel
diameter 4.5mm - 8.0mm) | Length
(mm)
11
20 | Diameter
(mm)
3
4
6
8
10
12
14
16
18
20
22 | Length
(mm)
6
6
6
7
7
9
10
12
14
16
18 | Diameter
(mm)
4
5
6
7
8 | Length
(mm)
10.0
10.5
11.0
12.5
13.5 | Diameter
(mm)
5.3
6.5
5.3 mm diameter used for target
vessel diameter 1.5-3.0 mm
6.5 diameter used for target vessel
diameter 3.0-5.0 mm | Length
(mm)
12
12 |
| Treatment Method | Permanent Implant | Permanent Implant | | Permanent Implant | | Permanent Implant | | |
| How Applied | Via catheter through guide sheath to
to target vessel | Via guiding catheter to the
target vessel | | Via guiding catheter to the
target vessel | | Via catheter through guide sheath to
target vessel | | |
12. Intended use of the ArtVentive Medical Group - Endoluminal Occlusion System (EOS)™:
The ArtVentive Medical Group Endoluminal Occlusion System™ (AVMG EOS™) is indicated for arterial and venous embolizations in the peripheral vasculature.
13. Performance Data:
Bench studies indicate that the ArtVentive Medical Group's EOS™ device performs as intended. The following testing was performed: dimensional design verification/validation, sterilization validation, transit and package integrity testing, GLP chronic animal safety testing, MRI compatibility, corrosion, radial strength and biocompatibility testing.
14. Substantial Equivalence:
The performance of the ArtVentive EOS demonstrates that the product is substantially equivalent to the performance of the predicate devices. The equivalence was shown through component materials and specifications, performance, biocompatibility testing, and sterilization validation. The AVMG EOS is substantially equivalent in intended use, design, technology/principles of operation, materials, and performance to the predicate devices. Differences between the devices do not raise any significant issues of safety or effectiveness.