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.

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

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Emboshield NAV6 Embolic Protection System:

This document describes a 510(k) submission for a medical device. It does not contain information about acceptance criteria or a study proving acceptance criteria related to AI/algorithm performance. The submission primarily focuses on establishing substantial equivalence to previously cleared predicate devices through bench testing, biocompatibility, sterilization, and aging data.

Therefore, many of the requested categories related to AI/algorithm performance studies cannot be filled from the provided text.

Here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

Based on the provided text, the "acceptance criteria" are implied by successful completion of various performance tests to demonstrate substantial equivalence to predicate devices. There are no specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) explicitly stated for the device's emboli capture effectiveness or other clinical outcomes, as this is a traditional medical device, not an AI/software device.

Acceptance Criterion (Implied)	Reported Device Performance
Biocompatibility (Cytotoxicity, Sensitization, Hemocompatibility, etc.)	Successfully completed
Simulated Use	Successfully completed
Loading/Deployment/Retrieval Forces	Successfully completed
Distal Preservation Flow (Flow Characteristics)	Successfully completed
Tensile Strength (Filtration Element Strength, Frame Integrity)	Successfully completed
Catheter Coating Integrity (Congo Red Test, Particulate Evaluation, Coating Delamination)	Successfully completed
Sterilization Validation (Non-pyrogenic)	Successfully completed
Shelf Life (2-year Accelerated Aging)	Successfully completed
Substantial Equivalence to Predicate Devices	Established - "is as safe, as effective, and performs as well as or better than the predicate devices."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size for test set: Not specified in the provided text for any of the performance tests. These are likely bench tests using a number of device units.
Data provenance: Not specified. Given the nature of the tests (bench, biocompatibility, sterilization, aging), they would typically be conducted in a laboratory setting.

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

Not applicable. This device is a physical medical device, not an AI/imaging device requiring expert ground truth for a test set. The "ground truth" for its performance is determined by established engineering and biological testing methods.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of expert interpretations for a test set.

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. This is not an AI-assisted device, and no MRMC study is mentioned.

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

No. This is not an algorithm, but a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Bench test results, biological assays, engineering measurements. The "ground truth" for this device's performance is derived from the objective results of the various performance tests listed (e.g., cytotoxicity assays, tensile strength measurements, flow dynamics, sterility tests).

8. The sample size for the training set

Not applicable. This device does not involve a training set as it is not an AI/machine learning device.

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

Not applicable.

Summary

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2.0 510(k) Summary

APR 2 9 2011

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	Abbott Vascular
Submitter's Address	3200 Lakeside Drive, Santa Clara, CA 95054
Telephone	(408) 845-0865
Fax	(408) 845-3743
Contact Person	Cherece L. Jones
Date of Submission	March 25, 2011
Device Trade Name	Emboshield NAV6 Embolic Protection System
Device Common Name	Embolic Protection System
Device Classification Name	Catheter, Carotid, Temporary, for EmbolizationCapture
Device Classification	Class II
Product Code	NTE
Predicate Device Names	Emboshield NAV6 Embolic Protection System(K081523)Emboshield NAV6 Embolic Protection System(K090665)
Summary of SubstantialEquivalence	Abbott Vascular has submitted bench,biocompatibility, sterilization and aging data toestablish that the proposed Emboshield NAV6Embolic Protection System is substantiallyequivalent to the predicate Emboshield NAV6devices.The proposed Emboshield NAV6 EmbolicProtection System has the same intended use asthe predicate devices. Testing results havedemonstrated that the Emboshield NAV6 EmbolicProtection System is as safe, as effective, andperforms as well as or better than the predicatedevices.

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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 (0.014") platinum/nickel radiopaque distal tip section. Three (3) BareWire designs are available as separately packaged items offering different support levels. The BareWire Workhorse is supplied with the Emboshield NAV6 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 (φ7.2 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:

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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:

. Biocompatibility
- o Cytotoxicity
- Sensitization o
- Hemocompatibility o
  - Hemolysis
  - . Complement Activation Test
- Material-Mediated Pyrogenicity o
- Bacterial Endotoxin o
- Intracutaneous Toxicity (Irritation) o
- O Acute Systemic Toxicity
Simulated Use .
Loading/Deployment/Retrieval Forces .
Distal Preservation Flow (Flow Characteristics) .
Tensile Strength .
- o Filtration Element Strength
- Frame Integrity O
Catheter Coating Integrity .
- Filtration Element Coating Integrity (Congo Red Test) o
- Particulate Evaluation O
- Coating Delamination o
Sterilization Validation .
- o Non-pyrogenic
Shelf Life (2-year 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 consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The caduceus is positioned to the right of the text, and the entire logo is presented in black and white.

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

Ms. Cherece L. Jones Regulatory Affairs Associate Abbott Vascular Inc. 3200 Lakeside Drive Santa Clara, CA 95054

APR 2 9 2011

Re: K110909

Trade/Device Name: Emboshield Nav Embolic Protection System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NTE Dated: March 30, 2011 Received: March 31-2011 --

Dear Ms. Jones:

We have reviewed your Section 510(k) premarket notification of intent to market the devicereferenced 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

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Page 2 – Ms. Cherece L. Jones

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Bram Zuckerman, M.D.

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

Enclosure

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1.0 Indications for Use Statement

Indications for Use 510(k) Number (if known): K || 0909

Indications For Use:

Prescription Use

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign Off)

n of Cardiovascular Devices

510(k) Number K110609

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).