(163 days)
Not Found
No
The summary describes a mechanical embolic protection device with filters and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is designed to capture and remove thrombus/debris dislodged during TAVR procedures, which aims to protect the patient from potential harm (e.g., stroke), thereby providing a therapeutic benefit by treating or preventing a condition.
No
Explanation: The device is described as an "embolic protection device" designed to capture and remove debris during a procedure, not to diagnose a condition.
No
The device description clearly outlines a physical, percutaneously delivered embolic protection system with filters, catheters, and other hardware components. There is no mention of software as the primary or sole component.
Based on the provided information, the Sentinel Cerebral Protection System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to capture and remove thrombus/debris during a medical procedure (transcatheter aortic valve replacement). This is a therapeutic and protective function performed in vivo (within the body).
- Device Description: The device is described as a percutaneously delivered embolic protection device with filters. This is a physical device used to intervene in the body.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide diagnostic information about a patient's condition. IVDs are used to diagnose, monitor, or screen for diseases or conditions by examining samples in vitro (outside the body).
The Sentinel Cerebral Protection System is a medical device used for intervention and protection during a surgical procedure, not for in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes
PUM
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brachiocephalic artery, left common carotid artery
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 (
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1251 Temporary catheter for embolic protection during transcatheter intracardiac procedures.
(a)
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.(b)
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ 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
300 Boston Scientific Way
Marlborough, Massachusetts 01752
USA |
|---------------------------------|-------------------------------------------------------------------------------------------------------|
| Contact Name and
Information | Eric Elliott
Three Scimed Place
Maple Grove, MN 55311-1566
Phone: 763-494-1654 |
| Date Prepared | September 06, 2019 |
| Proprietary Name | Sentinel™ Cerebral Protection System |
| Common Name | Temporary catheter, embolic protection, transcatheter
intracardiac procedures |
| Product Code | PUM |
| Classification | Class II, 21 CFR Part 870.1251 |
| Predicate Device | Sentinel Cerebral Protection System
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 ( ●
- 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.
5
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.