(105 days)
No
The device description and performance studies focus on mechanical properties and biocompatibility, with no mention of AI or ML algorithms for image analysis, decision support, or automated control.
No
The device is used to retrieve and/or manipulate objects during surgical procedures, not to treat a disease or condition.
No
This device is designed for retrieving and manipulating objects using minimally invasive surgical procedures, not for identifying the nature or cause of a disease or condition.
No
The device description clearly details physical components like an outer sheath, central core wire, pre-formed loop, and handle, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for retrieving and/or manipulating objects within the cardiovascular system and hollow viscous using minimally invasive surgical procedures. This is an in vivo application, meaning it is used within a living organism.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This device does not perform tests on samples.
- Device Description: The description details a physical snare used for mechanical manipulation, not for analyzing biological samples.
- Input Imaging Modality: The mention of "Fluoroscopy Visualization" further supports its use in a live patient during a procedure, not for analyzing samples in a lab.
Therefore, the Expro Elite and Sympro Elite snares are medical devices used for interventional procedures, not IVDs.
N/A
Intended Use / Indications for 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 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.
Product codes
MMX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiovascular system and hollow viscous
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)
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
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
1
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
2
Indications for Use
510(k) Number (if known)
Device Name Expro Elite Snare Sympro Elite Snare
Indications for Use (Describe)
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.
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
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.
4
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
5
- 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.