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 site of the Filtration Element placement should be between 2.5 and 7.0 mm.

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, RX Delivery Catheter, Filtration Element, and RX Retrieval Catheter.

AI/ML Overview

The provided text describes a 510(k) summary for the Emboshield NAV6 Embolic Protection System. It outlines the device description, its intended use, a comparison to predicate devices, and a list of performance tests conducted. However, it does not include information about acceptance criteria, specific study results demonstrating device performance against those criteria, or details regarding ground truth, expert involvement, or multi-reader studies.

The "Performance Data" section lists various tests performed (e.g., Bioburden Testing, Wire Movement, Coating Integrity, Particulate Testing, Biocompatibility). While these tests were "successfully completed," the document does not report specific metrics or thresholds that define "successful completion" for each test. Consequently, it's impossible to create a table of acceptance criteria and reported performance with quantitative data based on the provided text.

Here's an analysis of the requested information based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Quantitative/Qualitative)	Reported Device Performance
Bioburden Testing: (Implicitly: acceptable bioburden levels)	Successfully completed
Wire Movement: (Implicitly: smooth, controlled movement)	Successfully completed
Coating Integrity: (Implicitly: durable, intact coating)	Successfully completed
Particulate Testing: (Implicitly: acceptable particulate levels)	Successfully completed
Coating Adhesion Testing: (Implicitly: adequate adhesion)	Successfully completed
Friction Testing: (Implicitly: acceptable friction levels)	Successfully completed
Coating Thickness: (Implicitly: within specified range)	Successfully completed
Coating Appearance: (Implicitly: acceptable appearance)	Successfully completed
Biocompatibility: (Implicitly: non-toxic, non-allergenic, non-hemolytic, etc.)	Successfully completed
* Cytotoxicity	Successfully completed
* Hemocompatibility (Hemolysis, Complement Activation, Coagulation)	Successfully completed
* Acute Systemic Toxicity	Successfully completed
* Intracutaneous Toxicity (Irritation)	Successfully completed
* Sensitization	Successfully completed
* Material-Mediated Pyrogenicity	Successfully completed

Note: The provided text only states that these tests were "successfully completed." It does not provide any specific quantitative (e.g., "bioburden < X CFU," "friction < Y N") or detailed qualitative (e.g., "no visible particulates," "coating remained intact after Z cycles") acceptance criteria or the measured performance values.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified in the provided text. The document lists types of tests but not the number of units or samples tested for each.
Data Provenance: Not specified. The document does not indicate the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided as the document focuses on engineering and biocompatibility testing of a medical device, not diagnostic performance or interpretation by experts. Ground truth, in this context, would typically refer to objective measurements from laboratory tests rather than expert consensus on clinical data.

4. Adjudication method for the test set

This information is not provided. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies where multiple experts independently review data and then reconcile differences, which is not described here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was mentioned or implied. The device (Embolic Protection System) is a physical medical device designed to capture embolic material, not an AI-powered diagnostic tool that assists human readers. Therefore, this question is not applicable to the provided context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical device, not an algorithm.

7. The type of ground truth used

For the performance tests listed (e.g., Bioburden, Coating Integrity, Biocompatibility), the "ground truth" would be established by objective laboratory measurements and validated test methods (e.g., ISO standards). For example, for bioburden, the ground truth is the measured microbial load, compared against predefined acceptable limits. For coating integrity, it's the physical observation and measurement of the coating after stress, compared against engineering specifications. No clinical outcomes data or pathology reviews are mentioned for these specific performance tests.

8. The sample size for the training set

Not applicable. The device is a physical medical device, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As above, no training set is relevant for this type of device.

Summary

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JUL 2 2 2014 K141678

510(k) Summary

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

Abbott Vascular

3200 Lakeside Drive, Santa Clara, CA 95054

(408) 845-0696

(408) 845-3743

Jessica Kao

June 20, 2014

Emboshield NAV6 Embolic Protection System

Embolic Protection System

Catheter, Carotid, Temporary, for Embolization Capture

Class II

NTE

Emboshield NAV Embolic Protection System . (K081523)
Emboshield NAV6 Embolic Protection System . (K090665)
Emboshield NAV6 Embolic Protection System . (K110909)
. Emboshield NAV Embolic Protection System (K121015)
The proposed Emboshield NAV6 Embolic . Protection System is identical to the predicate except for the different PTFE coating on the Bare Wire Filter Delivery Wire.
The proposed Emboshield NAV6 Embolic . Protection System has the same intended use as the predicate devices.
Testing results have demonstrated that the . Emboshield NAV® Embolic Protection System is substantially equivalent to the predicate device.

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Device Description:

BareWire Filter Delivery Wire: .

The BareWire Filter Delivery Wire is a 0.014" PTFE coated stainless steel guidewire with a 3 cm platinum/nickel radiopaque distal tip section. Three (3) Bare Wire designs are available as separately packaged items that offer different support levels and wire lengths, 315 cm and 190 cm. A 190cm BareWire Workhorse is supplied with the Emboshield NAV Embolic Protection System.

. RX Delivery Catheter:

The RX Delivery Catheter usable length is 135 cm. The crossing profile is either 0.0365" or 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 radiopaque nitinol support structure . 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 (5.0 mm) to treat vessel diameters of 2.5 - 4.8 mm and large (7.2 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:

Comparisons to the predicate devices show that 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:

Bioburden Testing .
. Wire Movement
. Coating Integrity
Particulate Testing ●
Vendor Operational Qualification and Performance Qualification .
- Coating Adhesion Testing
- o Friction Testing
- Coating Thickness
- o Coating Appearance
Biocompatibility ●
- o Cytotoxicity
- o Hemocompatibility
  - Hemolysis, Direct and Indirect .
  - . Complement Activation Test
- Coagulation (PT and PTT) o
- Acute Systemic Toxicity o
- Intracutaneous Toxicity (Irritation) o
- o Sensitization
- Material-Mediated Pyrogenicity o

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird with three curved lines forming its body and wings.

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

July 22, 2014

Abbott Vascular Ms. Jessica Kao Regulatory Affairs Specialist 3200 Lakeside Drive Santa Clara, CA 95054

Re: K141678

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: June 20, 2014 Received: June 23, 2014

Dear Ms. Kao:

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 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.

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Page 2 - Ms. Jessica Kao

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/ReportalProblem/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,

Nicole Subrahim -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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Indications for Use

K141678 510(k) Number (if known):

Emboshield NAV6 Embolic Protection System Device Names:

The Emboshield NAV Embolic Protection System is indicated for Indications for Use: 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)

Regulation Number and Section

§ 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).