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 and while performing atherectomy, during standalone procedures or together with PTA and/or stenting, in lower extremity arteries. The diameter of the site of the Filtration Element should be between 2.5 and 7.0 mm.

Device Description

The Emboshield NAVO Embolic Protection System (EPS) is a temporary percutaneous transluminal filtration system designed to capture embolic material released during interventional procedures within carotid arteries or atherectomy in the arterial vasculature of the lower extremity. The system consists of the following components: BareWire Filter Delivery Wire, RX Delivery Catheter, Filtration Element and RX Retrieval Catheter and ancillary items which include loading funnel, flushing syringes, introducer tool and torque devices.

AI/ML Overview

Here's an analysis of the provided text, outlining the acceptance criteria and the study proving the device meets them, based on the requested categories.

Important Note: The provided text is a 510(k) summary for a medical device (Embolic Protection System), not an AI/ML device. Therefore, many of the requested categories related to AI model development, such as training sets, expert adjudication of ground truth, and MRMC studies, are not directly applicable or discussed in this document. The focus of this submission is on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and clinical data on safety and efficacy in an expanded indication for use.

Acceptance Criteria and Device Performance for Emboshield NAV6 Embolic Protection System (K191173)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Performance Goal)	Reported Device Performance
Clinical Performance	30-day Freedom from Major Adverse Events (MAE) rate of ≥ 83% (Performance Goal derived from similar devices in the same anatomy)	92.0% (Lower limit of 95% CI: 86.7%)
Non-Clinical Performance	Meets performance standards for: - Deployment and Retrieval Force - Simulated Use	The assessment concluded these tests should be performed, and the overall conclusion states the device met all acceptance criteria. (Specific pass/fail results for individual non-clinical tests are not detailed in this summary.)
Technological Equivalence	Show substantial equivalence to predicate in: - Intended Use - System Components - Technological Characteristics - Sterilization - Materials and Biocompatibility	"The conclusion of the comparison analysis is that the subject Emboshield NAV6 EPS is substantially equivalent to the predicate device."
Safety - Filter Specific	Low occurrence of events directly reflecting filter performance (distal embolization, perforation at filter level, unplanned amputation)	One case of distal embolization, no cases of perforation at the level of the filter, and no unplanned amputations among MAEs.
Overall Safety & Effectiveness	No new safety or effectiveness issues raised.	"The clinical and non-clinical data demonstrate that the subject Emboshield NAV6 EPS met all acceptance criteria and performed similarly to the predicate device and that no new safety or effectiveness issues were raised."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Clinical Study: n=162 patients.
Data Provenance: Retrospective clinical data from a "real-world population" of peripheral arterial disease (PAD) patients treated at the Mount Sinai Health Center (USA, implied by FDA submission context, though not explicitly stated as country of origin). The data represents routine clinical practice.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This document does not describe the use of experts to establish a "ground truth" for the clinical test set in the way it would be for an AI/ML diagnostic device. The clinical outcomes (MAE) were observed clinical events, not interpretations by experts for the purpose of a ground truth.
The MAE definition is a composite of clinical events (death, MI, thrombosis, dissection, distal embolization, perforation, unplanned amputation, TVR). These are typically determined by clinical observation and data collection according to study protocols, not expert consensus on image interpretation.

4. Adjudication Method for the Test Set

Not applicable in the context of this device. The clinical events (MAE) are observed outcomes, not interpretations requiring adjudication.

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

Not applicable. This is not an AI/ML device. The study evaluates the performance of a medical device (embolic protection system) in a clinical setting, not how human readers' diagnostic accuracy changes with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an AI/ML algorithm. The device's performance is measured in its intended use during a clinical procedure.

7. The Type of Ground Truth Used

The "ground truth" for the clinical study was the occurrence or non-occurrence of predefined clinical events (Major Adverse Events - MAE) in real-world patients. This can be considered a form of "outcomes data."
For non-clinical testing, the "ground truth" relies on predefined engineering specifications and simulated use outcomes.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device or an algorithm that requires a "training set" in the machine learning sense. The clinical data was used to demonstrate the device's performance in a real-world setting.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this type of medical device submission.

Summary

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July 25, 2019

Abbott Vascular Namratha Manthani Regulatory Affairs Manager 3200 Lakeside Drive Santa Clara, California 95054

Re: K191173

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: April 29, 2019 Received: May 1, 2019

Dear Ms. Manthani:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Misti Malone Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191173

Device Name Emboshield NAV6 Embolic Protection System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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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.

1. Submitter Information

Submitter's Name	Abbott Vascular
Submitter's Address	3200 Lakeside Drive, Santa Clara, Ca 95054
Telephone	(408) 845-0734
Fax	(408) 845-3743
Contact Person	Namratha Manthani
Date Prepared	July 3, 2019

2. Subject Device

Device Trade Name	Emboshield NAV6 Embolic Protection System
Device Common Name	Embolic Protection System
Device Classification Name	Catheter, Carotid, Temporary, for Embolization Capture

3. Predicate Device

Device Trade Name	Emboshield NAV6 Embolic Protection System
510(k) Number	K141678
510(k) Clearance Date	July 22, 2014

4. Device Description

5. Indications for Use

The Emboshield NAV6 Embolic Protection System is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid arteries and while performing atherectomy, during standalone procedures or together with PTA and/or stenting, in lower extremity arteries. The diameter of the artery at the Filtration Element placement should be between 2.5 and 7.0 mm.

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6. Technological Characteristics and Substantial equivalence

The subject Emboshield NAV6 EPS is identical to the currently marketed predicate device except for the changes listed below.

The changes made to the subject Emboshield NAV6 EPS are:

-Expansion of indication to include use while performing atherectomy in lower extremity arteries (LEA) and
-Additional IFU updates to contraindications, warnings, precautions and adverse events

A comparison between the subject Emboshield NAV6 EPS and its predicate was performed to support a substantial equivalence determination. The substantial equivalence comparison included the device's intended use, system components, technological characteristics, sterilization, materials and biocompatibility. The conclusion of the comparison analysis is that the subject Emboshield NAV6 EPS is substantially equivalent to the predicate device.

7. Performance Data

To demonstrate substantial equivalence of the subject Emboshield NAV® EPS to the predicate device for the expansion of the indication to lower extremity arteries, non-clinical and clinical assessments were performed.

For the additional labeling changes, no additional performance data was required, as these changes only modify and add content to the IFU without any impact to the operation and/or the performance of the device.

7.1 Non-Clinical Data

To demonstrate substantial equivalence of the subject Emboshield NAV EPS to the predicate device, technological characteristics and performance criteria were evaluated. An assessment of testing to be repeated was performed in accordance with the Guidance for Industry and FDA Staff - Coronary and Carotid Embolic Protection Devices -Premarket Notification [510(k)] Submissions (Document Issued on: February 15, 2008) The assessment concluded that the following tests should be performed:

. Deployment and Retrieval Force Test
Simulated Use .

In addition, a study was performed to quantify the tortuosity along the device pathway for endovascular therapy involving the carotid arteries and lower extremity region. The comparison of tortuosity between carotid and lower extremity regions was made using computed tomography angiography (CTA) data from existing patients.

7.2 Clinical Data

To support an indication expansion to include LEA use, clinical data in a real-world population of peripheral arterial disease (PAD) patients treated for lower extremity lesions with atherectomy and an embolic protection device in routine clinical practice at the Mount Sinai Health Center

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was analyzed (Emboshield NAV6 EPS, n=162). The patient population evaluated was representative of complex PAD with a high degree of commonly associated comorbidities. To assess the safety and efficacy of Emboshield NAV EPS in this anatomy, a composite rate of major adverse events (MAE) was calculated. MAE is defined as a composite of death, myocardial infarction (MI), thrombosis, dissection (grade C or greater), distal embolization (DE), perforation at the level of the filter, unplanned amputation and target vessel revascularization (TVR). The primary analysis outcome of freedom from MAE was compared against a performance goal (PG) of 83%, derived from the performance of similar devices in the same anatomy.

The 30-day freedom from MAE rate for Emboshield NAV6 EPS was 92.0%, in which the lower limit of the two-sided 95% confidence interval was 86.7%, meeting the pre-specified PG of 83%. The MAEs that occurred included one death, two MIs, one thrombosis, eight dissections, and one DE. The MAE rate contains several components and reflects the success and/or complications of the overall procedure and less directly information about the performance of the filter itself. The most commonly observed issues with filters are the likelihood that emboli may escape the filter or the device itself might knock emboli loose and result in DE and associated outcomes. Therefore, occurrence of DE, perforation at the level of the filter, and subsequent unplanned amputation best reflect the performance of the filter. Of the MAE components that are considered most relevant to the evaluation of Emboshield NAV EPS, there was one case of DE and no cases of perforation at the level of the filter and no unplanned amputations.

In the analysis of real-world Emboshield NAV6 EPS data, the freedom of MAE rate met the prespecified PG. The patients evaluated showed few adverse events related to filter performance. The patients in this analysis represent a real-world population of PAD with associated comorbidities. Their complex lesions were treated in routine clinical practice and all treatment decisions were made per operator discretion. Thus, this data represents real-world Emboshield NAV6 EPS usage in the treatment of femoral popliteal lesions.

The clinical and non-clinical data demonstrate that the subject Emboshield NAV6 EPS met all acceptance criteria and performed similarly to the predicate device and that no new safety or effectiveness issues were raised. Therefore, the subject Emboshield NAV EPS can be considered substantially equivalent to the predicate device.

8. Conclusions

Based on the intended use, system components, technological characteristics, sterilization, materials and biocompatibility and performance data included in this submission. Abbott Vascular considers the subject Emboshield NAV6 EPS to be substantially equivalent to the currently marketed Emboshield NAV6 EPS (K141678).

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).