(44 days)
Not Found
No
The device description and performance studies focus on mechanical components and bench testing, with no mention of AI/ML algorithms or data processing beyond fluoroscopic visualization.
No
The device is used to remove a vena cava filter, which is a therapeutic intervention, but the device itself is an instrument for removal, not a device that directly treats a disease or condition.
No
Explanation: The device is used for the retrieval of vena cava filters, which is a therapeutic intervention, not for diagnosing a condition. Its function involves physical removal, not diagnosis.
No
The device description explicitly details physical components like a Nitinol Snare, Snare Catheter Assembly, Retrieval Sheath, and Dilator Assembly, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Bard® Snare Retrieval Kit is a surgical device used to physically remove a medical implant (a vena cava filter) from within the body. It is used in vivo (within a living organism), not in vitro (in a test tube or laboratory setting).
- Intended Use: The intended use clearly states "to percutaneously remove all Bard optional vena cava filters with a retrieval hook." This describes a surgical procedure, not a diagnostic test on a sample.
- Device Description: The description details the physical components of the device (snare, catheter, sheath, dilator) used for the retrieval procedure.
- Input Imaging Modality: Fluoroscopic visualization is used to guide the surgical procedure, not to analyze a biological sample.
- Anatomical Site: The vena cava is a blood vessel within the body, the site of the surgical intervention.
Therefore, based on the provided information, the Bard® Snare Retrieval Kit is a medical device used for a surgical procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Bard® Snare Retrieval Kit is intended for use to percutaneously remove all Bard optional vena cava filters with a retrieval hook.
Product codes (comma separated list FDA assigned to the subject device)
MMX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vena cava
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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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
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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.
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 PRAStaff@fda.hhs.gov
"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."
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6.0 510(K) SUMMARY
| Applicant: | NeoMetrics, Inc.
2605 Fernbrook Lane North, Suite J
Plymouth, MN 55447 |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dave Liebl, President and Chief Technology Officer
2605 Fernbrook Lane North, Suite J
Plymouth, MN 55447 |
| Date Prepared: | September 8, 2015 |
| Trade Name: | Bard® Snare Retrieval Kit |
| Common or
Usual Name: | Device, Percutaneous Retrieval |
| Classification: | Class II |
| Regulation Number: | 21 CFR 870.5150 |
| Product Code: | MMX |
| Review Panel: | Cardiovascular Devices |
| Predicate
Device: | The subject device is substantially equivalent to K073374; Günther
Tulip™ Vena Cava Filter Retrieval Set manufactured by Cook
Medical. |
| Device
Description: | 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. |
| Indication for
Use: | The Bard® Snare Retrieval Kit is intended for use to percutaneously
remove all Bard optional vena cava filters with a retrieval hook. |
| Principle and
Mechanism of
Operation: | Mechanically snare the hook of the Vena Cava Filter, advance the
sheath to collapse the filter and remove. |
| Functional and
Safety Testing: | 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. |
| Comparative
Technology
Characteristics | A comparison of the characteristics of the proposed device and the
predicate device shows the Bard® Snare Retrieval Kit to have the
same technological characteristics to the predicate which has received
510(k) clearance.
Equivalence is based upon intended use, indications for use, operating
principle and fundamental scientific technology. Both devices are
catheter based systems that have collapsible wires for filter
engagement and withdrawal into an outer sheath. Both systems are
designed to be used over a guidewire. Both devices contain marker
bands for visibility and both have similar dimensions.
Both devices have similar materials of construction, dimensions, and
designs. Minor difference does exist in dimensions and material
These minor differences in technological characteristics do not raise
different questions of safety and effectiveness. |
| Non-Clinical
Tests Submitted | The following tests were performed to support Bard® Snare Retrieval
Kit'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 be
equivalent to the predicate device. This conclusion is based upon the
fact that device has an equivalent intended use, and there are no
differences that raise new types of questions of safety and
effectiveness. |
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