Bard Snare Retrieval Kit

K152560 · Neometrics, Inc. · MMX · Oct 23, 2015 · Cardiovascular

Device Facts

• Record ID: K152560
• Device Name: Bard Snare Retrieval Kit
• Applicant: Neometrics, Inc.
• Product Code: MMX · Cardiovascular
• Decision Date: Oct 23, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bard® Snare Retrieval Kit is intended for use to percutaneously remove all Bard optional vena cava filters with a retrieval hook.

Device Story

The Bard® Snare Retrieval Kit is a percutaneous catheter-based system used by physicians to remove optional vena cava filters. The device consists of a nitinol snare (20 mm diameter loop), a 6 French snare catheter assembly, and an 11 French O.D. retrieval sheath with a 9 French dilator. During operation, the physician uses fluoroscopic guidance to navigate the snare to the filter hook. The nitinol snare mechanically engages the filter hook; the retrieval sheath is then advanced over the filter to collapse it into the sheath for withdrawal. Radiopaque marker bands on the snare catheter, retrieval sheath, and access sheath facilitate visualization. The device enables minimally invasive filter removal, potentially reducing patient risk compared to surgical alternatives.

Clinical Evidence

Bench testing only. Performance testing included catheter tensile strength, liquid leakage, corrosion resistance, snare assembly torque strength, and simulated use. Biocompatibility testing included cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), irritation/intracutaneous reactivity (ISO 10993-10), acute systemic toxicity (ISO 10993-11), pyrogenicity (ISO 10993-11), and hemocompatibility/thromboresistance/coagulation (ISO 10993-4).

Technological Characteristics

Catheter-based system; Nitinol snare (20 mm diameter); 6 French snare catheter; 11 French O.D. retrieval sheath; 9 French dilator; Radiopaque marker bands for fluoroscopic visualization; Designed for use over a guidewire; Materials tested per ISO 10993 standards.

Indications for Use

Indicated for percutaneous removal of Bard optional vena cava filters with a retrieval hook in patients requiring filter retrieval.

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

• Günther Tulip™ Vena Cava Filter Retrieval Set (K073374)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping to create a sense of depth and connection. The profiles are rendered in a simple, line-art style.

Public Health Service

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

October 23, 2015

NeoMetrics, Inc. Mr. David Liebl President and Chief Technology Officer 2605 Fernbrook Lane North, Suite J Plymouth, MN 55447

Re: K152560

Trade/Device Name: Bard® Snare Retrieval Kit Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: MMX Dated: September 8, 2015 Received: September 9, 2015

Dear Mr. Liebl:

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 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

{1}------------------------------------------------

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/Resourcesfor You/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 [phone] or [phone] or at its Internet address

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

Sincerely yours,

# Kenneth J. Cavanaugh -S

for

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

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K152560

Device Name Bard® Snare Retrieval Kit

Indications for Use (Describe)

The Bard® Snare Retrieval Kit is intended for use to percutaneously remove all Bard optional vena cava filters with a retrieval hook.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

#### 6.0 510(K) SUMMARY

| Applicant: | NeoMetrics, Inc.<br>2605 Fernbrook Lane North, Suite J<br>Plymouth, MN 55447 |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dave Liebl, President and Chief Technology Officer<br>2605 Fernbrook Lane North, Suite J<br>Plymouth, MN 55447 |
| Date Prepared: | September 8, 2015 |
| Trade Name: | Bard® Snare Retrieval Kit |
| Common or<br>Usual Name: | Device, Percutaneous Retrieval |
| Classification: | Class II |
| Regulation Number: | 21 CFR 870.5150 |
| Product Code: | MMX |
| Review Panel: | Cardiovascular Devices |
| Predicate<br>Device: | The subject device is substantially equivalent to K073374; Günther<br>Tulip™ Vena Cava Filter Retrieval Set manufactured by Cook<br>Medical. |
| Device<br>Description: | The Bard® Snare Retrieval Kit is intended to percutaneously remove<br>Bard filters from the vena cava.<br>The Bard® Snare Retrieval Kit consists of a Nitinol Snare with 6<br>French Snare Catheter Assembly and a 11 French O.D Retrieval<br>Sheath with 9 French Dilator Assembly.<br>The nitinol snare has a 20 mm diameter (fully expanded) radiopaque<br>loop and comes preloaded in the snare catheter. The snare catheter,<br>retrieval sheath, and access sheath have radiopaque marker bands at<br>the distal ends for enhanced fluoroscopic visualization. |
| Indication for<br>Use: | The Bard® Snare Retrieval Kit is intended for use to percutaneously<br>remove all Bard optional vena cava filters with a retrieval hook. |
| Principle and<br>Mechanism of<br>Operation: | Mechanically snare the hook of the Vena Cava Filter, advance the<br>sheath to collapse the filter and remove. |
| Functional and<br>Safety Testing: | To verify that device design meets functional and performance<br>requirements, representative samples of the device underwent bench<br>testing in accordance with applicable standards and guidance.<br>These data provide an acceptable assurance of the safety and<br>effectiveness of the Bard® Snare Retrieval Kit and demonstrate the<br>device is equivalent to the predicate. |
| Comparative<br>Technology<br>Characteristics | A comparison of the characteristics of the proposed device and the<br>predicate device shows the Bard® Snare Retrieval Kit to have the<br>same technological characteristics to the predicate which has received<br>510(k) clearance.<br><br>Equivalence is based upon intended use, indications for use, operating<br>principle and fundamental scientific technology. Both devices are<br>catheter based systems that have collapsible wires for filter<br>engagement and withdrawal into an outer sheath. Both systems are<br>designed to be used over a guidewire. Both devices contain marker<br>bands for visibility and both have similar dimensions.<br>Both devices have similar materials of construction, dimensions, and<br>designs. Minor difference does exist in dimensions and material<br>These minor differences in technological characteristics do not raise<br>different questions of safety and effectiveness. |
| Non-Clinical<br>Tests Submitted | The following tests were performed to support Bard® Snare Retrieval<br>Kit's substantial equivalence.<br>Performance Testing, including: Catheter Tensile Strength Catheter Liquid Leakage Catheter Corrosion Resistance Snare Assembly Torque Strength Snare Simulated Use Biocompatibility Testing, including: Cytotoxicity (ISO 10993-5) Sensitization (ISO 10993-10) Irritation - Intracutaneous Reactivity (ISO10993-10) Acute Systemic Toxicity (ISO10993-11) Pyrogenicity (ISO 10993-11) Hemocompatibility Thromboresistance Coagulation (ISO 10993-4) |
| Conclusion: | NeoMetrics Inc. considers the Bard® Snare Retrieval Kit to be<br>equivalent to the predicate device. This conclusion is based upon the<br>fact that device has an equivalent intended use, and there are no<br>differences that raise new types of questions of safety and<br>effectiveness. |

{4}------------------------------------------------