(80 days)
Not Found
No
The device description and performance studies focus on mechanical components and in vitro testing, with no mention of AI/ML, image processing, or data-driven performance metrics.
Yes
The device is indicated for the non-surgical removal of emboli and thrombi from blood vessels and synthetic grafts, which are therapeutic interventions.
No
The device is indicated for the non-surgical removal of emboli and thrombi, not for diagnosing conditions. Its description outlines a system for mechanical thrombectomy and aspiration.
No
The device description clearly outlines physical components (catheter, clot retractor) and mechanical actions (expanding funnel, aspiration, pulling matter), 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 Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- MegaVac System Function: The MegaVac Mechanical Thrombectomy System is a device used within the body (intravascularly) to physically remove blood clots (thrombi and emboli) from blood vessels and synthetic grafts. It also facilitates temporary occlusion, fluid injection/aspiration, and catheter placement.
- Lack of Specimen Analysis: The device does not analyze any biological specimens in vitro (outside the body). Its function is entirely mechanical and interventional within the patient's circulatory system.
The description clearly outlines a device used for a therapeutic procedure (removing clots) and other interventional actions directly within the patient's body, which is the domain of medical devices, not IVDs.
N/A
Intended Use / Indications for Use
The MegaVac Mechanical Thrombectomy System is indicated for:
- The non-surgical removal of emboli and thrombi from blood vessels.
- The non-surgical removal of thrombi from synthetic grafts.
- Use in temporary blood vessel/graft occlusion.
- Injection, infusion, and/or aspiration of contrast media and other fluids into or from a vessel/graft
- Catheter placement over a guidewire
Product codes
DXE
Device Description
The MegaVac Mechanical Thrombectomy System consists of two single-use devices, the MegaVac Catheter with SafeSeal technology and a ThromboWire clot retractor, for intravascular mechanical thrombectomy, occlusion, aspiration and embolectomy. The MegaVac Catheter with SafeSeal technology utilizes a silicone coated nitinol braided funnel that expands to occlude antegrade blood flow proximal to the target work zone creating a static environment in which to perform the intervention, while also centering and securing the catheter tip position within the vessel. The MegaVac catheter's large-mouth funnel and inner diameter allows for strong aspiration while easily being able to pass the ThromboWire and other lesion disruptive or therapeutic devices through it. The ThromboWire consists of a nitinol embolectomy element that when expanded by the proximal actuation handle can serve to gather and pull matter towards and through the MegaVac catheter during aspiration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
blood vessels, synthetic grafts
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)
Device evaluation consisted of in vitro testing and supports the substantial equivalence of the MegaVac Thrombectomy system to the predicate device. All data met the acceptance criteria and fell within pre-determined product specifications and industry standard requirements.
Functional, Dimensional and Mechanical Testing:
- Occlusion
- Aspiration
- Trackability over guidewire
- Retraction
- Handle stroke
- Leakage
- Tensile
- Diameters, length
- Component compatibility (obturator/Thrombowire)
Biocompatibility Testing: In accordance with 10993-1 for devices categorized as an "external communicating device in contact with circulating blood with limited exposure time (
§ 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).
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Image /page/1/Picture/0 description: The image is a logo for Capture Vascular Inc. The logo features a stylized graphic on the left, consisting of red, gray, and white curved shapes. To the right of the graphic is the company name, "CAPTURE" in large, red, sans-serif letters, with "VASCULAR INC." in smaller, black letters underneath.
510(k) Summary for MegaVac Mechanical Thrombectomy System
a) General Information
| Submitter: | Capture Vascular, Inc.
620 Mountain Village Blvd., Suite 2c
Mountain Village, CO 81435 |
|----------------------------|----------------------------------------------------------------------------------------------|
| Contact Person: | Aaron Call
SVP
480. 559. 8819 |
| Summary Preparation Date: | July 11, 2017 |
| Names | |
| Trade Name: | MegaVac Mechanical Thrombectomy System |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Embolectomy Catheter |
| Product Code: | DXE |
| Regulatory Classification: | 21 CFR 870.5150 |
c) Predicate Device
b)
- Genesis Medical Interventional™ F.A.S.T. TM (Facilitated Aspiration/Suction ● Thrombectomy) System (K040010)
- . F.A.S.T. SED (Self-Expanding Device) and CXD (Controlled Expansion Device) System (K092623)
d) Product Description
The MegaVac Mechanical Thrombectomy System consists of two single-use devices, the MegaVac Catheter with SafeSeal technology and a ThromboWire clot retractor, for intravascular mechanical thrombectomy, occlusion, aspiration and embolectomy. The MegaVac Catheter with SafeSeal technology utilizes a silicone coated nitinol braided funnel that expands to occlude antegrade blood flow proximal to the target work zone creating a static environment in which to perform the intervention, while also centering and securing the catheter tip position within the vessel. The MegaVac catheter's large-mouth funnel and inner diameter allows for strong aspiration while easily being able to pass the ThromboWire and other lesion disruptive or therapeutic devices through it. The
2
Image /page/2/Picture/0 description: The image is a logo for Capture Vascular Inc. The logo features a stylized graphic on the left, consisting of red, white, and black shapes that resemble a stylized heart or blood vessel. To the right of the graphic, the words "CAPTURE" and "VASCULAR INC." are written in red and black, respectively. The word "CAPTURE" is on the top line, and "VASCULAR INC." is on the bottom line.
ThromboWire consists of a nitinol embolectomy element that when expanded by the proximal actuation handle can serve to gather and pull matter towards and through the MegaVac catheter during aspiration.
e) Indications for Use
The MegaVac Mechanical Thrombectomy System is indicated for:
- The non-surgical removal of emboli and thrombi from blood vessels.
- The non-surgical removal of thrombi from synthetic grafts.
- Use in temporary blood vessel/graft occlusion.
- Injection, infusion, and/or aspiration of contrast media and other fluids into or from a vessel/graft
- Catheter placement over a guidewire
f) Rationale for Substantial Equivalence
The MegaVac Mechanical Thrombectomy System and the predicates share the same or similar intended use and technological characteristics and therefore are substantially equivalent.
A comparison of the similarities and differences of the technological characteristics between the new device and the predicates is shown below.
| K171493 | K092623 | K040010 | |||
|---|---|---|---|---|---|
| MegaVac Mechanical | |||||
| Thrombectomy System | F.A.S.T. Controlled | ||||
| Expanding Device | |||||
| (CXD) | Genesis Medical Interventional | ||||
| F.A.S.T. System | |||||
| Device | |||||
| Component | MegaVac Catheter | ThromboWire | |||
| (Clot Retractor) | Expanding Basket | ||||
| Thrombectomy | |||||
| Guidewire | Funnel Sheath | ||||
| catheter | Expanding Basket | ||||
| Thrombectomy | |||||
| Guidewire | |||||
| Basket or Funnel | |||||
| Composition | Polymer coated | ||||
| woven nitinol | Woven nitinol | Woven nitinol | Polymer coated | ||
| woven nitinol | Woven nitinol | ||||
| Material | Silicone coated | ||||
| nitinol braided | |||||
| funnel | Nitinol | Nitinol | Silicone coated | ||
| nitinol braided | |||||
| funnel | Nitinol | ||||
| Device Profile | |||||
| Dimensions | Up to 9 Fr | .5mm - 1.5mm | 0.46mm | Up to 9 Fr | 0.914mm |
| (Typical) | |||||
| Device Lengths | Up to 300cm | Up to 300cm | 195cm | Up to 300cm | Up to 300cm |
| Deployed | |||||
| Diameter | 2 – 12mm | 2 – 9mm | 5.5mm | 2 – 12mm | 2 – 9mm |
| Deployment | |||||
| Mechanism | Operator | ||||
| controlled - linear | |||||
| actuation | Operator | ||||
| controlled - linear | |||||
| actuation | Operator controlled - | ||||
| rotational knob | Operator | ||||
| controlled - linear | |||||
| actuation | Operator | ||||
| controlled - linear | |||||
| actuation | |||||
| Guidewire | |||||
| compatibility | Up to 0.044" OD | N/A | N/A | Up to 0.044" OD | N/A |
g) Safety and Effectiveness Information
The MegaVac system is substantially equivalent to the predicate devices regarding its similar intended use, design, function, materials and sterilization method. In accordance
3
with Capture Vascular's risk analysis and according to international standards, verification testing was conducted on the MegaVac Mechanical Thrombectomy System. A summary of the verification testing conducted on the MegaVac Mechanical Thrombectomy is described below.
Summary of Testing:
Device evaluation consisted of in vitro testing and supports the substantial equivalence of the MegaVac Thrombectomy system to the predicate device. All data met the acceptance criteria and fell within pre-determined product specifications and industry standard requirements. The following is a list of tests that were performed:
. Functional, Dimensional and Mechanical Testing
- Occlusion o
- Aspiration O
- Trackability over guidewire O
- Retraction O
- Handle stroke O
- Leakage O
- Tensile O
- Diameters, length o
- Component compatibility (obturator/Thrombowire) O
● Biocompatibility Testing:
In accordance with 10993-1 for devices categorized as an "external communicating device in contact with circulating blood with limited exposure time (