Sentinel Cerebral Protection System

K192460 · Boston Scientific Corporation · PUM · Feb 19, 2020 · Cardiovascular

Device Facts

• Record ID: K192460
• Device Name: Sentinel Cerebral Protection System
• Applicant: Boston Scientific Corporation
• Product Code: PUM · Cardiovascular
• Decision Date: Feb 19, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1251
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Sentinel Cerebral Protection System is indicated for use as an embolic protection device to capture and remove thrombus/debris while performing transcatheter aortic valve replacement procedures. The diameters of the arteries at the site of filter placement should be between 9 - 15 mm for the brachiocephalic and 6.5 - 10 mm in the left common carotid.

Device Story

Sentinel CPS is a 6 French, 95 cm, single-use, percutaneously delivered embolic protection device; inserted via radial or brachial artery. System deploys two filters: proximal filter in brachiocephalic artery; distal filter in left common carotid artery. Captures and removes debris dislodged during TAVR procedures. At procedure completion, filters and captured debris are recaptured into catheter and removed from patient. Used in clinical setting by physicians. Benefits patient by reducing risk of embolic events during TAVR.

Clinical Evidence

Bench testing only. Verification activities included simulated use deployment/retrieval force testing, dimensional verification of filter pore size, tensile characterization of filter film, and shelf-life evaluation. Biocompatibility testing conducted per ISO 10993-1, including cytotoxicity, sensitization, reactivity, systemic injection, pyrogenicity, hemolysis, complement activation, and PTT/platelet/leucocyte testing.

Technological Characteristics

6 French, 95 cm catheter; dual-filter system (proximal 15 mm, distal 10 mm). Materials include polyurethane filter film. Delivered percutaneously via radial or brachial artery. Sterile, single-use. No electronic components or software.

Indications for Use

Indicated for patients undergoing transcatheter aortic valve replacement (TAVR) procedures to capture and remove embolic thrombus/debris. Requires target vessel diameters of 9-15 mm for the brachiocephalic artery and 6.5-10 mm for the left common carotid artery.

Regulatory Classification

Identification

This device is a single use percutaneous catheter system that has (a) blood filter(s) at the distal end. This device is indicated for use while performing transcatheter intracardiac procedures. The device is used to filter blood in a manner that may prevent embolic material (thrombus/debris) from the transcatheter intracardiac procedure from traveling towards the cerebral circulation.

Special Controls

In combination with the general controls of the FD&C Act, the Sentinel® Cerebral Protection System is subject to the following special controls:

*Classification.* Class II (special controls). The special controls for this device are:(1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Simulated-use testing in a clinically relevant bench anatomic model to assess the following: (A) Delivery, deployment, and retrieval, including quantifying deployment and retrieval forces, and procedural time; and (B) Device compatibility and lack of interference with the transcatheter intracardiac procedure and device. (ii) Tensile strengths of joints and components, tip flexibility, torque strength, torque response, and kink resistance. (iii) Flow characteristics. (A) The ability of the filter to not impede blood flow. (B) The amount of time the filter can be deployed in position and/or retrieved from its location without disrupting blood flow. (iv) Characterization and verification of all dimensions. (2) Animal testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be assessed: (i) Delivery, deployment, and retrieval, including quantifying procedural time. (ii) Device compatibility and lack of interference with the transcatheter intracardiac procedure and device. (iii) Flow characteristics. (A) The ability of the filter to not impede blood flow. (B) The amount of time the filter can be deployed in position and/or retrieved from its location without disrupting blood flow. (iv) Gross pathology and histopathology assessing vascular injury and downstream embolization. (3) All patient contacting components of the device must be demonstrated to be biocompatible. (4) Performance data must demonstrate the sterility of the device components intended to be provided sterile. (5) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life. (6) Labeling for the device must include: (i) Instructions for use; (ii) Compatible transcatheter intracardiac procedure devices; (iii) A detailed summary of the clinical testing conducted; and (iv) A shelf life and storage conditions. (7) Clinical performance testing must demonstrate: (i) The ability to safely deliver, deploy, and remove the device; (ii) The ability of the device to filter embolic material while not impeding blood flow; (iii) Secure positioning and stability of the position throughout the transcatheter intracardiac procedure; and (iv) Evaluation of all adverse events including death, stroke, and vascular injury.

Predicate Devices

• Sentinel Cerebral Protection System (DEN160043)

Submission Summary (Full Text)

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February 19, 2020

Boston Scientific Corporation Eric Elliott Regulatory Affairs Manager Three Scimed Place Maple Grove, Minnesota 55311-1566

Re: K192460

Trade/Device Name: Sentinel Cerebral Protection System Regulation Number: 21 CFR 870.1251 Regulation Name: Temporary Catheter for Embolic Protection During Transcatheter Intracardiac Procedures Regulatory Class: Class II Product Code: PUM Dated: January 17, 2020 Received: January 21, 2020

Dear Mr. Elliott:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jaime Raben, Ph.D. Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular 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)

#### K192460

Device Name Sentinel Cerebral Protection System

Indications for Use (Describe)

The Sentinel Cerebral Protection System is indicated for use as an embolic protection device to capture and remove thrombus/debris while performing transcatheter aortic valve replacement procedures. The diameters of the arteries at the site of filter placement should be between 9 - 15 mm for the brachiocephalic and 6.5 - 10 mm in the left common carotid.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary per 21 CFR §807.92

| Sponsor | Boston Scientific Corporation<br>300 Boston Scientific Way<br>Marlborough, Massachusetts 01752<br>USA |
|---------------------------------|-------------------------------------------------------------------------------------------------------|
| Contact Name and<br>Information | Eric Elliott<br>Three Scimed Place<br>Maple Grove, MN 55311-1566<br>Phone: [phone] |
| Date Prepared | September 06, 2019 |
| Proprietary Name | Sentinel™ Cerebral Protection System |
| Common Name | Temporary catheter, embolic protection, transcatheter<br>intracardiac procedures |
| Product Code | PUM |
| Classification | Class II, 21 CFR Part 870.1251 |
| Predicate Device | Sentinel Cerebral Protection System<br>DEN160043 June 1, 2017 |

### Device Description

The Sentinel™ Cerebral Protection System (Sentinel CPS) is a 6 French, 95 cm working length, single use, temporary, percutaneously delivered embolic protection device, inserted into the radial or brachial artery. The system is designed to capture and remove debris dislodged during transcatheter aortic valve replacement (TAVR) procedures. The Sentinel CPS utilizes an embolic filter delivered to the brachiocephalic artery (Proximal Filter) and a second embolic filter delivered to the left common carotid artery (Distal Filter). At the completion of the procedure, the filters and debris are recaptured into the catheter and removed from the patient. The device is provided sterile and is single-use only.

The Sentinel CPS is available with a Proximal Filter size of 15 mm (target vessel size of 9 - 15 mm) and a Distal Filter size of 10 mm (target vessel size of 6.5 - 10 mm).

### Indications for Use / Intended Use

The Sentinel Cerebral Protection System is indicated for use as an embolic protection device to capture and remove thrombus/debris while performing transcatheter aortic valve replacement procedures. The diameters of the arteries at the site of filter placement should be between 9 – 15 mm for the brachiocephalic and 6.5 – 10 mm in the left common carotid.

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## Comparison of Technological Characteristics

Replacement of filter film polyurethane material with a similar polyurethane is required due to material obsolescence by the supplier. Comparisons of the new and currently marketed predicate device cleared under DEN160043 show that the technological characteristics such as filter performance, materials, design, sterilization, packaging, and intended use/ indications for use are substantially equivalent. The subject Sentinel Cerebral Protection System indications for use, design, and principles of operation are identical to the currently marketed predicate cleared under DEN160043.

### Non-clinical Performance Data

Modifications to the predicate device were assessed according to risk-based failure mode effects analysis and with consideration of FDA Guidance. Coronary and Carotid Embolic Protection Devices - Premarket Notification [510(k)] Submission (issued February 15, 2008). The following non-clinical testing was successfully completed on the modified device.

- Simulated Use Proximal and Distal Filter Deployment Force ●
- Simulated Use Proximal and Distal Filter Retrieval Force .
- Dimensional Verification Filter Pore Size ●
- Tensile Characterization Filter Film .
- . Shelf Life Evaluation

Testing demonstrated that the modified Sentinel Cerebral Protection System met all previously established acceptance criteria. No new safety or effectiveness issues were raised during verification and validation activities; thereby supporting a determination of substantial equivalence.

Biocompatibility testing was also assessed with consideration of evaluation recommendations per ISO 10993-1, Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process and FDA Guidance on ISO 10993-1 (issued June 16, 2016) for devices categorized as externally communicating with limited (<24 hours) direct circulating blood contact. The following is a list of biocompatibility tests conducted on the modified Sentinel Cerebral Protection System.

- MEM Elution Cytotoxicity .
- . Guinea Pig Maximization Sensitization
- Intracutaneous Reactivity ●
- Acute Systemic Injection ●
- . Material Mediated Rabbit Pyrogen
- Hemolysis (direct and extract methods) ●
- . Complement Activation (SC5b-9 method)
- USP Physiochemical test <661> ●
- Natural Rubber Latex ELISA Inhibition Assay for Antigenic Protein ●
- Partial Thromboplastin Time (PTT) ●
- Platelet/Leucocyte testing

Results confirm that the modified device remains biocompatible for its intended use.

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## Conclusion

Successful design verification and biocompatibility testing support substantial equivalency of the Sentinel Cerebral Protection System to the currently marketed predicate device. There were no new safety or effectiveness issues raised during verification and testing activities.