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 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.

AI/ML Overview

The provided document is a 510(k) Summary for the MegaVac Mechanical Thrombectomy System. This regulatory submission primarily focuses on establishing substantial equivalence to predicate devices based on design, function, materials, sterilization, and in vitro testing. It does not contain information about clinical studies (comparative effectiveness or standalone), sample sizes for test or training sets for AI devices, expert qualifications for ground truth establishment, or adjudication methods, as these are typically associated with performance evaluations of AI/ML-based devices or clinical trials rather than a 510(k) submission for a traditional medical device demonstrating substantial equivalence through bench testing.

Therefore, many of the requested details related to AI device performance evaluation are not present in this document.

Here's the information that can be extracted:

Acceptance Criteria and Device Performance

1. A table of acceptance criteria and the reported device performance

The document states: "All data met the acceptance criteria and fell within pre-determined product specifications and industry standard requirements." However, specific numerical acceptance criteria for each test are not provided. The table below lists the tests performed and the general statement about meeting acceptance criteria.

Test Category	Specific Test Performed	Reported Device Performance
Functional, Dimensional and Mechanical Testing	Occlusion	Met acceptance criteria and pre-determined product specifications
	Aspiration	Met acceptance criteria and pre-determined product specifications
	Trackability over guidewire	Met acceptance criteria and pre-determined product specifications
	Retraction	Met acceptance criteria and pre-determined product specifications
	Handle stroke	Met acceptance criteria and pre-determined product specifications
	Leakage	Met acceptance criteria and pre-determined product specifications
	Tensile	Met acceptance criteria and pre-determined product specifications
	Diameters, length	Met acceptance criteria and pre-determined product specifications
	Component compatibility (obturator/Thrombowire)	Met acceptance criteria and pre-determined product specifications
Biocompatibility Testing	In accordance with 10993-1 for external communicating device in contact with circulating blood with limited exposure time (<24 hours).	Met acceptance criteria and pre-determined product specifications
Sterilization Testing	In accordance with ANSI/AAMI/ISO 11135.	Met acceptance criteria and pre-determined product specifications
Transportation and Shelf Life Testing	Ship testing in accordance with ASTM D4169.	Met acceptance criteria and pre-determined product specifications
	Shelf life testing in accordance with ASTM F1980-07.	Met acceptance criteria and pre-determined product specifications

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for any of the in vitro tests. The testing was in vitro (bench testing) and therefore does not have "country of origin" or "retrospective/prospective" data provenance in the clinical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This was in vitro (bench) testing of a physical medical device, not an AI/ML device relying on expert-established ground truth from medical images or clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This was in vitro (bench) testing of a physical medical device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. The document explicitly states: "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." Therefore, no MRMC study, AI assistance, or effect size was reported.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This device is not an algorithm or AI product. It is a physical mechanical thrombectomy system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the in vitro tests, "ground truth" would be established by the pre-determined product specifications, engineering designs, and industry standard requirements. For example, for "diameters, length," the ground truth would be the design specifications for those dimensions.

8. The sample size for the training set

Not applicable. This device is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable. This device is not an AI/ML device.

Summary

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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 2cMountain Village, CO 81435
Contact Person:	Aaron CallSVP480. 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

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

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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 MechanicalThrombectomy System		F.A.S.T. ControlledExpanding Device(CXD)	Genesis Medical InterventionalF.A.S.T. System
DeviceComponent	MegaVac Catheter	ThromboWire(Clot Retractor)	Expanding BasketThrombectomyGuidewire	Funnel Sheathcatheter	Expanding BasketThrombectomyGuidewire
Basket or FunnelComposition	Polymer coatedwoven nitinol	Woven nitinol	Woven nitinol	Polymer coatedwoven nitinol	Woven nitinol
Material	Silicone coatednitinol braidedfunnel	Nitinol	Nitinol	Silicone coatednitinol braidedfunnel	Nitinol
Device ProfileDimensions	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
DeployedDiameter	2 – 12mm	2 – 9mm	5.5mm	2 – 12mm	2 – 9mm
DeploymentMechanism	Operatorcontrolled - linearactuation	Operatorcontrolled - linearactuation	Operator controlled -rotational knob	Operatorcontrolled - linearactuation	Operatorcontrolled - linearactuation
Guidewirecompatibility	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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

Regulation Number and Section

§ 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).