MegaVac Mechanical Thrombectomy System

K171493 · Capture Vascular, Inc. · QEX · Aug 10, 2017 · Cardiovascular

Device Facts

• Record ID: K171493
• Device Name: MegaVac Mechanical Thrombectomy System
• Applicant: Capture Vascular, Inc.
• Product Code: QEX · Cardiovascular
• Decision Date: Aug 10, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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

Device Story

MegaVac Mechanical Thrombectomy System comprises MegaVac Catheter and ThromboWire clot retractor; used for intravascular mechanical thrombectomy, occlusion, and aspiration. Catheter features silicone-coated nitinol braided funnel; expands to occlude antegrade blood flow proximal to target zone; creates static environment for intervention; centers/secures catheter tip. ThromboWire utilizes nitinol embolectomy element; expanded via proximal actuation handle; gathers/pulls matter through catheter during aspiration. Operated by physicians in clinical settings. Large-mouth funnel allows strong aspiration and passage of lesion disruptive/therapeutic devices. Benefits patient via non-surgical removal of emboli/thrombi.

Clinical Evidence

No clinical data generated. Substantial equivalence established via bench testing only. Testing included functional/mechanical evaluations (occlusion, aspiration, trackability, retraction, handle stroke, leakage, tensile, component compatibility), biocompatibility (ISO 10993-1), sterilization (ISO 11135), and transportation/shelf-life (ASTM D4169, ASTM F1980-07). All results met acceptance criteria.

Technological Characteristics

Materials: silicone-coated nitinol braided funnel, nitinol embolectomy element. Dimensions: up to 9 Fr catheter, 2-12mm deployed diameter. Deployment: operator-controlled linear actuation. Connectivity: standalone. Sterilization: per ANSI/AAMI/ISO 11135. Mechanical principle: funnel-based flow occlusion and aspiration.

Indications for Use

Indicated for non-surgical removal of emboli and thrombi from blood vessels and synthetic grafts; temporary blood vessel/graft occlusion; injection/infusion/aspiration of fluids; and catheter placement over a guidewire.

Regulatory Classification

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.

Predicate Devices

• 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)

Submission Summary (Full Text)

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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.<br>620 Mountain Village Blvd., Suite 2c<br>Mountain Village, CO 81435 |
|----------------------------|----------------------------------------------------------------------------------------------|
| Contact Person: | Aaron Call<br>SVP<br>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

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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<br>Thrombectomy System | | F.A.S.T. Controlled<br>Expanding Device<br>(CXD) | Genesis Medical Interventional<br>F.A.S.T. System | |
| Device<br>Component | MegaVac Catheter | ThromboWire<br>(Clot Retractor) | Expanding Basket<br>Thrombectomy<br>Guidewire | Funnel Sheath<br>catheter | Expanding Basket<br>Thrombectomy<br>Guidewire |
| Basket or Funnel<br>Composition | Polymer coated<br>woven nitinol | Woven nitinol | Woven nitinol | Polymer coated<br>woven nitinol | Woven nitinol |
| Material | Silicone coated<br>nitinol braided<br>funnel | Nitinol | Nitinol | Silicone coated<br>nitinol braided<br>funnel | Nitinol |
| Device Profile<br>Dimensions | Up to 9 Fr | .5mm - 1.5mm | 0.46mm | Up to 9 Fr | 0.914mm<br>(Typical) |
| Device Lengths | Up to 300cm | Up to 300cm | 195cm | Up to 300cm | Up to 300cm |
| Deployed<br>Diameter | 2 – 12mm | 2 – 9mm | 5.5mm | 2 – 12mm | 2 – 9mm |
| Deployment<br>Mechanism | Operator<br>controlled - linear<br>actuation | Operator<br>controlled - linear<br>actuation | Operator controlled -<br>rotational knob | Operator<br>controlled - linear<br>actuation | Operator<br>controlled - linear<br>actuation |
| Guidewire<br>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

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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 (<24 hours)."

#### ● Sterilization Testing:

A sterilization assessment was conducted in accordance with ANSI/AAMI/ISO 11135.

#### . Transportation and Shelf Life Testing:

Ship testing was conducted in accordance with ASTM D4169. Shelf life testing was conducted in accordance with ASTM F1980-07.

#### ● Summary of Pre-Clinical and Clinical Data:

No Clinical Data was generated to establish substantial equivalence. Bench data and pre-clinical data are considered adequate to support a determination of substantial equivalence.

### h) Conclusion

As described in this 510(k) Summary, the MegaVac Mechanical Thrombectomy System is substantially equivalent to the Genesis Medical Interventional™ F.A.S.T. TM (Facilitated Aspiration/Suction Thrombectomy) System based on a comparison of intended uses and the results of in-vitro testing.

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Public Health Service

Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 10, 2017

Capture Vascular, Inc. Aaron Call Senior Vice President 620 Mountain Village Blvd. Suite 2c Mountain Village, Colorado 81435

Re: K171493

Trade/Device Name: MegaVac Mechanical Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: July 11, 2017 Received: July 13, 2017

Dear Aaron Call:

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure