(44 days)
The Bard® Snare Retrieval Kit is intended for use to percutaneously remove all Bard optional vena cava filters with a retrieval hook.
The Bard® Snare Retrieval Kit is intended to percutaneously remove Bard filters from the vena cava.
The Bard® Snare Retrieval Kit consists of a Nitinol Snare with 6 French Snare Catheter Assembly and a 11 French O.D Retrieval Sheath with 9 French Dilator Assembly.
The nitinol snare has a 20 mm diameter (fully expanded) radiopaque loop and comes preloaded in the snare catheter. The snare catheter, retrieval sheath, and access sheath have radiopaque marker bands at the distal ends for enhanced fluoroscopic visualization.
This document is a 510(k) summary for the Bard® Snare Retrieval Kit, a medical device intended for percutaneous removal of Bard optional vena cava filters with a retrieval hook. It is a submission to the FDA seeking clearance for market.
The document does not describe an acceptance criteria and study proving a device meets said criteria in the context of an AI/ML algorithm or software. Instead, it describes the process of establishing substantial equivalence for a physical medical device (the Bard® Snare Retrieval Kit) to a legally marketed predicate device (Günther™ Tulip™ Vena Cava Filter Retrieval Set).
Therefore none of the requested information regarding AI/ML performance acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details can be extracted from this document.
The "Functional and Safety Testing" section states: "To verify that device design meets functional and performance requirements, representative samples of the device underwent bench testing in accordance with applicable standards and guidance. These data provide an acceptable assurance of the safety and effectiveness of the Bard® Snare Retrieval Kit and demonstrate the device is equivalent to the predicate."
The "Non-Clinical Tests Submitted" section lists the types of tests performed:
- Performance Testing: Catheter Tensile Strength, Catheter Liquid Leakage, Catheter Corrosion Resistance, Snare Assembly Torque Strength, Snare Simulated Use.
- Biocompatibility Testing: 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).
However, the specific acceptance criteria for each of these tests and their corresponding quantitative performance results are not provided in this summary. The summary only states that these tests were performed to show substantial equivalence to the predicate device.
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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
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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/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 (800) 638-2041 or (301) 796-7100 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
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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)
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.
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6.0 510(K) SUMMARY
| Applicant: | NeoMetrics, Inc.2605 Fernbrook Lane North, Suite JPlymouth, MN 55447 |
|---|---|
| Contact Person: | Dave Liebl, President and Chief Technology Officer2605 Fernbrook Lane North, Suite JPlymouth, MN 55447 |
| Date Prepared: | September 8, 2015 |
| Trade Name: | Bard® Snare Retrieval Kit |
| Common orUsual Name: | Device, Percutaneous Retrieval |
| Classification: | Class II |
| Regulation Number: | 21 CFR 870.5150 |
| Product Code: | MMX |
| Review Panel: | Cardiovascular Devices |
| PredicateDevice: | The subject device is substantially equivalent to K073374; GüntherTulip™ Vena Cava Filter Retrieval Set manufactured by CookMedical. |
| DeviceDescription: | The Bard® Snare Retrieval Kit is intended to percutaneously removeBard filters from the vena cava.The Bard® Snare Retrieval Kit consists of a Nitinol Snare with 6French Snare Catheter Assembly and a 11 French O.D RetrievalSheath with 9 French Dilator Assembly.The nitinol snare has a 20 mm diameter (fully expanded) radiopaqueloop and comes preloaded in the snare catheter. The snare catheter,retrieval sheath, and access sheath have radiopaque marker bands atthe distal ends for enhanced fluoroscopic visualization. |
| Indication forUse: | The Bard® Snare Retrieval Kit is intended for use to percutaneouslyremove all Bard optional vena cava filters with a retrieval hook. |
| Principle andMechanism ofOperation: | Mechanically snare the hook of the Vena Cava Filter, advance thesheath to collapse the filter and remove. |
| Functional andSafety Testing: | To verify that device design meets functional and performancerequirements, representative samples of the device underwent benchtesting in accordance with applicable standards and guidance.These data provide an acceptable assurance of the safety andeffectiveness of the Bard® Snare Retrieval Kit and demonstrate thedevice is equivalent to the predicate. |
| ComparativeTechnologyCharacteristics | A comparison of the characteristics of the proposed device and thepredicate device shows the Bard® Snare Retrieval Kit to have thesame technological characteristics to the predicate which has received510(k) clearance.Equivalence is based upon intended use, indications for use, operatingprinciple and fundamental scientific technology. Both devices arecatheter based systems that have collapsible wires for filterengagement and withdrawal into an outer sheath. Both systems aredesigned to be used over a guidewire. Both devices contain markerbands for visibility and both have similar dimensions.Both devices have similar materials of construction, dimensions, anddesigns. Minor difference does exist in dimensions and materialThese minor differences in technological characteristics do not raisedifferent questions of safety and effectiveness. |
| Non-ClinicalTests Submitted | The following tests were performed to support Bard® Snare RetrievalKit's substantial equivalence.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 beequivalent to the predicate device. This conclusion is based upon thefact that device has an equivalent intended use, and there are nodifferences that raise new types of questions of safety andeffectiveness. |
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§ 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).