(85 days)
No
The summary describes a mechanical filtration system and does not mention any AI/ML components or capabilities.
Yes
The device is designed to contain and remove embolic material, which is a direct therapeutic intervention to prevent complications during angioplasty, stenting, and atherectomy procedures.
No
The device is an embolic protection system designed to capture embolic material released during interventional procedures, not to diagnose a condition.
No
The device description clearly lists multiple hardware components (BareWire Filter Delivery Wire, RX Delivery Catheter, Filtration Element, RX Retrieval Catheter, loading funnel, flushing syringes, introducer tool, torque devices).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used during a medical procedure (angioplasty, stenting, atherectomy) to physically capture embolic material within the body. This is an in vivo (within the living body) application, not an in vitro (outside the living body) diagnostic test.
- Device Description: The description details a physical system with components like wires, catheters, and a filtration element designed for mechanical intervention within the body. This aligns with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is purely mechanical and interventional.
Therefore, the Emboshield NAV Embolic Protection System is an in vivo medical device, not an IVD.
N/A
Intended Use / Indications 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 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.
Product codes
NTE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
computed tomography angiography (CTA)
Anatomical Site
carotid arteries, lower extremity arteries
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
To demonstrate substantial equivalence of the subject Emboshield NAV6 EPS to the predicate device for the expansion of the indication to lower extremity arteries, non-clinical and clinical assessments were performed.
Non-Clinical Data
- Study Type: Performance testing (Deployment and Retrieval Force Test, Simulated Use) and tortuosity study.
- Sample Size: Not specified for performance tests. Tortuosity study used CTA data from existing patients.
- Data Source: Not specified for performance tests. Existing patient CTA data for tortuosity study.
- Key Results: The assessment concluded that Deployment and Retrieval Force Test and Simulated Use should be performed. A study quantified the tortuosity along the device pathway for endovascular therapy involving carotid and lower extremity regions using CTA data. Comparison of tortuosity was made between these regions.
Clinical Data
- Study Type: Retrospective analysis of real-world clinical data.
- Sample Size: n=162 (patients treated with Emboshield NAV6 EPS).
- Data Source: Real-world population of peripheral arterial disease (PAD) patients treated at the Mount Sinai Health Center.
- Key Results: The 30-day freedom from MAE rate for Emboshield NAV6 EPS was 92.0%, with a lower limit of the two-sided 95% confidence interval of 86.7%. This met the pre-specified performance goal (PG) of 83%. MAEs that occurred included one death, two MIs, one thrombosis, eight dissections, and one DE. Only one case of DE was observed, and no cases of perforation at the level of the filter or unplanned amputations occurred. The study concluded that the device met all acceptance criteria and performed similarly to the predicate device, raising no new safety or effectiveness issues.
Key Metrics
- 30-day freedom from MAE rate: 92.0%
- Lower limit of the two-sided 95% confidence interval: 86.7%
- Performance Goal (PG): 83%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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
1
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)
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.
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
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.
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).