(30 days)
The Emboshield NAV6 Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus / debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of the Filtration Element placement should be between 2.5 and 7.0 mm.
The Emboshield NAV Embolic Protection System (EPS) is a temporary percutaneous transluminal filtration system designed to capture embolic material released during angioplasty and stent procedures within carotid arteries. The system consists of the following components: BareWire Filter Delivery Wire, RX Delivery Catheter, Filtration Element, and RX Retrieval Catheter.
The provided text describes a 510(k) summary for the Emboshield NAV® Embolic Protection System. It outlines the device description, its intended use, and states that a modification was made to the adhesive used for a radiopaque marker on the delivery catheter. The document then lists performance tests conducted to demonstrate substantial equivalence to predicate devices.
However, the provided text does not contain the detailed acceptance criteria for specific performance metrics, nor does it present a study that directly proves the device meets those criteria in the typical format of a clinical trial or algorithm performance study.
The "Performance Data" section merely lists the types of tests conducted (biocompatibility and tensile testing for marker band integrity). It does not provide:
- Quantitative acceptance criteria (e.g., "tensile strength must exceed X N with a P-value < 0.05").
- Reported device performance values for these criteria.
- Sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details. These are all elements typically associated with studies demonstrating the effectiveness or accuracy of medical devices, especially those involving image analysis or clinical outcomes.
The submission is for a modification to an existing device (K110909), specifically a change in adhesive for a radiopaque marker. The review focuses on demonstrating that this change does not negatively impact the substantial equivalence to the predicate device, rather than providing a comprehensive de novo validation of the device's clinical performance.
Therefore, I cannot populate the requested table or answer the specific questions regarding sample size, expert ground truth, MRMC, or standalone studies based on the provided document. The document confirms that "Performance testing was successfully completed" and lists the types of tests, but not their results or methodology in detail sufficient to answer your query.
Summary based on available information:
| Aspect | Description |
|---|---|
| 1. Acceptance Criteria & Reported Performance | Not provided in the document. The document states that "Performance testing was successfully completed" and lists categories of tests (Biocompatibility: Cytotoxicity, Hemocompatibility, Coagulation, Acute Systemic Toxicity, Intracutaneous Toxicity, Sensitization, Material-Mediated Pyrogenicity; Tensile Testing: Marker Band Integrity Baseline, and 2 and 3 years Accelerated Aging). However, specific quantitative acceptance criteria or the numerical results of these tests are not detailed. The submission is focused on demonstrating that the modification (adhesive change) does not alter the substantial equivalence, implying that the device continues to meet the criteria established for the predicate device, but these criteria themselves are not listed. |
| 2. Sample size and data provenance | Not applicable/Not provided. The tests listed (biocompatibility, tensile testing) are material/device property tests, not clinical or image |
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121015
MAY - 4 2012
510(k) Summary
Abbott Vascular
The 510(k) Summary is submitted in accordance with 21 CFR §807.92 and the requirements of the Safe Medical Device Act (SMDA) of 1990.
Submitter's Name
Submitter's Address
Telephone
Fax
Contact Person
Date of Submission
Device Trade Name
Device Common Name
Device Classification Name
Device Classification
Product Code
Predicate Device Names
Summary of Substantial Equivalence
(408) 845-0682 (408) 845-3743 Ivalee Cohen March 30, 2012 Emboshield NAV® Embolic Protection System Embolic Protection System Catheter, Carotid, Temporary, for Embolization Capture
3200 Lakeside Drive, Santa Clara, CA 95054
Class II
NTE
- Emboshield NAV6 Embolic Protection System . (K081523)
- Emboshield NAV6 Embolic Protection System . (K090665)
- Emboshield NAV6 Embolic Protection System . (K110909)
- The proposed Emboshield NAV6 Embolic . Protection System has the same intended use as the predicate devices.
- Testing results have demonstrated that the ● Emboshield NAV6 Embolic Protection System is substantially equivalent to the predicate device.
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Device Description:
The Emboshield NAV Embolic Protection System (EPS) is a temporary percutaneous transluminal filtration system designed to capture embolic material released during angioplasty and stent procedures within carotid arteries. The system consists of the following components:
. BareWire Filter Delivery Wire:
The BareWire Filter Delivery Wire is a 0.014" PTFE coated stainless steel guidewire with a 3 cm (0.014") platinum/nickel radiopaque distal tip section. Three (3) Bare Wire designs are available as separately packaged items offering different support levels. The BareWire Workhorse is supplied with the Emboshield NAV Embolic Protection System and is available packaged separately in two lengths, 315 cm and 190 cm.
RX Delivery Catheter: .
The RX Delivery Catheter usable length is 135 cm. The crossing profile is between 0.0365" and 0.0415", depending on Filtration Element size. A pull handle is used to deploy the loaded Filtration Element from the pod. Two (2) pairs of indicator bands are provided along the catheter shaft; a proximal pair (90 cm and 100 cm from the catheter tip) to indicate the catheter tip position during advancement through the guide catheter, and a distal pair to indicate the proximity of the RX exit port during catheter retraction. A radiopaque marker band is positioned proximal to the pod.
. Filtration Element:
The Filtration Element consists of a nylon membrane with an internal nitinol support structure with radiopaque coils. There are two proximal triangular entry ports and multiple 120 micron distal perfusion pores. There is also a proximal and a distal marker band. The Filtration Element is available in two sizes: small (φ5.0 mm) to treat vessel diameters of 2.5 - 4.8 mm and large (67.2 mm) to treat vessel diameters of 4.0 to 7.0 mm.
RX Retrieval Catheter: .
The RX Retrieval Catheter has a usable length of 139 cm and a molded expansile distal tip with a maximum outer diameter of 0.067". A handle is situated at the proximal end. Two pairs of marker bands indicate the position of the Retrieval Catheter RX guidewire exit port and catheter tip.
Indication for Use:
The Emboshield NAV Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus / debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the Filtration Element placement should be between 2.5 and 7.0 mm.
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Technological Characteristics:
The modification being implemented is to change the adhesive used to attach the radiopaque marker onto the delivery catheter component of the NAV system. No other changes were made to the device cleared under K110909. Therefore, the technological characteristics such as product performance, design and intended use are substantially equivalent to the current marketed predicate devices.
Performance Data:
Performance testing was successfully completed on the Emboshield NAV6 Embolic Protection System. The following tests were conducted:
- Biocompatibility .
- o Cytotoxicity
- o Hemocompatibility
- Hemolysis, Direct and Indirect ■
- l Complement Activation Test
- Coagulation (PT and PTT) o
- Acute Systemic Toxicity o
- Intracutaneous Toxicity (Irritation) o
- o Sensitization
- o Material-Mediated Pyrogenicity
- Tensile Testing: Marker Band Integrity Baseline, and 2 and 3 years Accelerated Aging
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY - 4 2012
Ms. Ivalee Cohen Manager, Regulatory Affairs Abbott Vascular Inc. 3200 Lakeside Drive Santa Clara, CA 95054
Re: K121015
Trade/Device Name: Emboshield Nav6 Embolic Protection System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NTE Dated: March 30, 2012 Received: April 4, 2012
Dear Ms. Cohen:
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
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Page 2 - Ms. Ivalee Cohen
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
M. A. Killebrew
Bram 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): _ K12 |0 |S
Device Names:
Emboshield NAV6 Embolic Protection System
Indications for Use:
The Emboshield NAV6 Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus / debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of the Filtration Element placement should be between 2.5 and 7.0 mm.
Prescription Use X (Per 21 CFR 801 Subpart D) OR
Over-The-Counter (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M. S. Killebrew
(Division Sign-Off)
Division of Cardiovascular Devices
Page
510(k) Number_K12 1015
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).