The Expro Elite and Sympro Elite snares are intended for use in the cardiovascular system and hollow viscous to retrieve and/or manipulate objects using minimally invasive surgical procedures include retrieval and/ or repositioning of intravascular foreign objects such as coils, balloons, catheters and/or guidewires within the cardiovascular system. This device is not intended for use in the coronary arteries or neurovasculature.

Device Description

The Expro Elite and Sympro Elite snares consist of an 0.035" outer sheath and a moveable central core wire with a pre-formed loop on the distal end. The outer sheath acts as a lumen through which the central core wire slides. The snare loop is radiopaque and can be advanced out of and retracted into the outer sheath by advancing or retracting the central core wire while holding the sheath stationary. A sheath grip tab on the proximal end of the sheath aids the user as they manipulate the handle during snare deployment. The snares have a rocker switch locking mechanism handle that allows for secure capture of an item by locking the sheath and core wire together as one unit, which offers the operator flexibility in maneuvering an object.

The outer sheath profile of the Expro and Sympro models is 0.035" (0.889 mm) and they are capable of being advanced through the lumen of a 0.035" inner diameter catheter. The outer sheath comprises a tri-layer polymer shaft and the distal snare loop construction is a Nitinol core covered with a gold tungsten coil.

The Expro Elite snare consists of one helical shaped loop and the Sympro Elite snare consists of one, round loop with a 90° angle to the snare shaft. Both snares are available in five loop diameters - 5 mm, 10 mm, 15 mm, and 35 mm. The Expro models vary in maximum loop length (26 mm to 80 mm) depending on the loop diameter.

AI/ML Overview

This document describes a 510(k) premarket notification for the Expro Elite Snare and Sympro Elite Snare devices. It does not pertain to an AI/ML medical device, but rather to a physical medical device (a snare for retrieving foreign objects). Therefore, many of the requested items related to AI/ML device testing (e.g., sample size for test set, data provenance, number of experts, MRMC studies, standalone performance, training set details) are not applicable to this document.

However, I can extract the information relevant to the device's acceptance criteria and the studies performed to prove it meets them, based on the provided text.

Device Name: Expro Elite Snare, Sympro Elite Snare

Device Type: Medical Device (Physical Snare) - Not an AI/ML device.

Here's the information extracted from the document:

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

The document states: "The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues." However, the specific quantitative acceptance criteria and the precise numerical performance results for each test are not provided in this summary. Instead, it lists the types of tests performed.

Test Performed	Acceptance Criteria (Not Quantified in Document)	Reported Device Performance (Not Quantified in Document)
Retraction Force from Packaging	Met specified criteria	Passed
Deployment and Retraction Simulated Use	Met specified criteria	Passed
Deployment Force in Simulated Anatomy	Met specified criteria	Passed
Retraction Force in Simulated Anatomy	Met specified criteria	Passed
Deployed Snare Length	Met specified criteria	Passed
Retracted Snare Length	Met specified criteria	Passed
Torque Response	Met specified criteria	Passed
Snare Handle Lock Break Free Force	Met specified criteria	Passed
Snare Handle Lock Force	Met specified criteria	Passed
Fluoroscopy Visualization	Met specified criteria	Passed
Full Unit Tensile	Met specified criteria	Passed
Peak Tensile Force	Met specified criteria	Passed
Kink Radius	Met specified criteria	Passed
Torque Strength	Met specified criteria	Passed
Dimensional Analysis	Met specified criteria	Passed
Corrosion Resistance	Met specified criteria	Passed
Cytotoxicity (ISO 10993-1)	Met specified criteria	Passed
Sensitization (ISO 10993-1)	Met specified criteria	Passed
Irritation (ISO 10993-1)	Met specified criteria	Passed
Systemic Toxicity (ISO 10993-1)	Met specified criteria	Passed
Pyrogenicity (ISO 10993-1)	Met specified criteria	Passed
Hemocompatibility (ISO 10993-1)	Met specified criteria	Passed

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

This document describes bench testing and biocompatibility testing of a physical device, not an AI/ML test set. Therefore, "sample size for the test set" in the context of data points/images is not applicable. The document does not specify the number of physical units tested for each bench test. Data provenance (country of origin, retrospective/prospective) is also not applicable as it's not a study involving patient data.

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 is not an AI/ML device relying on human expert annotation to establish ground truth.

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

Not applicable. This is not an AI/ML device requiring human adjudication of data.

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

Not applicable. This is not an AI/ML device, and no MRMC study was performed. The document explicitly states: "Clinical testing was not performed."

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

Not applicable. This is not an AI/ML algorithm. The performance evaluation was of the physical device's mechanical and material properties.

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

For this physical device, the "ground truth" is defined by the engineering specifications and performance criteria established for the device's function (e.g., specific force thresholds, dimensional tolerances, material compatibility standards). The document indicates that the tests conform to established standards like ISO 10993-1 for biocompatibility.

8. The sample size for the training set

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

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

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

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

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

March 8, 2017

Vascular Solutions, Inc. Jake Schultz Regulatory Product Specialist 6464 Sycamore Court North Minneapolis, MN 55369

Re: K163307

Trade/Device Name: Expro Elite Snare, Sympro Elite Snare Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: MMX Dated: February 3, 2017 Received: February 6, 2017

Dear Jake Schultz:

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 mav 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 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.

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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" (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,

Fernando Aguel -
Fernando Aguel
S

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

Enclosure

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Indications for Use

510(k) Number (if known)

K163307

Device Name Expro Elite Snare Sympro Elite Snare

Indications for Use (Describe)

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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510(k) Summary

[As required by 21 CFR 807.92]

Date Prepared: 3/01/17

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Submitter's Name / Contact Person

Manufacturer	Contact Person
Vascular Solutions, Inc.	Jake Schultz
6464 Sycamore Court North	Regulatory Product Specialist
Minneapolis, MN 55369 USA	Tel: 763-656-4300
Establishment Registration # 2134812	Fax: 763-656-4253

General Information

Trade Name	Expro Elite and Sympro Elite snares
Common / Usual Name	Percutaneous Retrieval Device
Classification Name	21 CFR 870.5150, MMX, Percutaneous Retrieval Device, Class I
Predicate Device	K071457, Expro Elite Snare, Vascular Solutions, Inc.
Reference Device	K972511, Amplatz Goose Neck Snare

Device Description

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Intended Use

The Expro Elite and Sympro Elite snares are intended for use in the cardiovascular system and hollow viscous to retrieve and/or manipulate objects using minimally invasive surgical procedures. Manipulation procedures include retrieval and/or repositioning of intravascular foreign objects such as coils, balloons, catheters and/or guidewires within the cardiovascular system. This device is not intended for use in the coronary arteries or neurovasculature.

Technological Characteristics Comparison

The Expro Elite and Sympro Elite snares are similar in design and identical in intended use to the predicate devices as they are a 0.035" platform used to retrieve or manipulate objects during minimally invasive surgical procedures and achieve this intended use through the variety of configurations with varying loop shapes and diameters.

The differences of the Expro Elite and Sympro Elite snares to the predicate device include new materials and an enhanced locking mechanism.

Substantial Equivalence and Summary of Studies

The technological differences between the subject and predicate devices have been evaluated through biocompatibility and bench tests to provide evidence of substantial equivalence. Clinical testing was not performed. The Expro Elite and Sympro Elite snares are substantially equivalent to the specified predicate device based on comparisons of the device functionality, technological characteristics, and indications for use. The device design has been verified through the following tests:

Retraction Force from Packaging
Deployment and Retraction Simulated Use ●
Deployment Force in Simulated Anatomy ●
Retraction Force in Simulated Anatomy ●
. Deployed Snare Length
Retracted Snare Length
Torque Response
Snare Handle Lock Break Free Force
Snare Handle Lock Force
. Fluoroscopy Visualization
Full Unit Tensile ●
. Peak Tensile Force
. Kink Radius
Torque Strength ●
Dimensional Analysis ●
Corrosion Resistance

Device samples passed the following biocompatibility tests performed in accordance with ISO 10993-1:

. Cytotoxicity

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Sensitization ●
. Irritation
Systemic Toxicity .
Pyrogenicity .
. Hemocompatibility

The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues. Therefore, the Expro Elite and Sympro Elite snares are substantially equivalent to the predicate device.

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).