(344 days)
The SentEP system is intended for use as a medical imaging system that allows the review, and media interchange of multi-dimensional digital images. It is also intended for intraprocedural use. The SentEP system is designed as an additional visualization modality to assist the clinician. The SentEP system is indicated for use in electrophysiology (EP) procedures to assist the clinician in visualization of the heart electroanatomic data.
The SentEP system is an imaging system intended to be used as an adjunct product to assist the clinician in visualization of the heart anatomy during cardiac catheter mapping and ablation procedures. Images are imported from an EAMS (electroanatomic mapping system) and displayed through the SentEP system. As a result, users can view both the 2D EAMS display monitor and the 3D SentEP system display at the same time.
Here's an analysis of the provided text to extract information about the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Metric) | Target Performance | Reported Device Performance |
|---|---|---|
| Navigational Capability (Time to 5 locations) | Within allocated time (60s per location) | The study evaluated "the ability to navigate to 5 locations within allocated time (60s per location)" comparing the SentEP system to the EAMS system. The comparison of performance data supports the conclusion that the SentEP system "was found to have a safety and effectiveness profile that is similar to the legally marketed EAMS system," implying it met this criterion. Explicit pass/fail rates or average times are not provided, but the statement suggests successful navigation within the time limit. |
| Point Location Accuracy | Not explicitly stated as a target, evaluated for comparison | The study evaluated "point location accuracy" comparing the SentEP system to the EAMS system. The conclusion that the SentEP system "was found to have a safety and effectiveness profile that is similar to the legally marketed EAMS system" suggests its accuracy was comparable and acceptable. Specific quantitative accuracy metrics (e.g., mm deviation) are not provided. |
| Usability/User Comfort | Positive Physician Exit Survey responses | The study assessed "the usability of the SentEP system by assessing the user comfort of the device" through "Physician Exit Survey responses." The overall conclusion about similar safety and effectiveness profile implies positive feedback and acceptable comfort levels. |
| Safety (Adverse Events) | No adverse events | "No adverse events were reported during this study." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: 16 pediatric EP patients.
- Data Provenance:
- Country of Origin: United States.
- Study Design: Prospective, acute, single-center study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications for the test set. The study refers to "the operator" (an Electrophysiologist, EP) performing procedures and navigating to intended targets, implying that the EP's actions and outcomes (time to target, point location) were the basis of evaluation. Since it's a navigational/visualization aid, the ground truth is likely based on the actual patient anatomy as confirmed by the EAMS system and the EP's clinical judgment during the procedure. The study evaluates the SentEP system against the EAMS system and the operator's ability to use it.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not mention a specific adjudication method like 2+1 or 3+1. The study design sounds more like a direct comparison or evaluation where the operator's performance with the SentEP system (in conjunction with EAMS) was measured against established clinical targets (navigating to 5 locations within 60s). Because it's an intraprocedural visualization aid, the "ground truth" for navigation and location accuracy is likely inherent in the real-time clinical context and the EAMS data itself, rather than a separate expert review process for each case.
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
The study was not a typical MRMC comparative effectiveness study in the sense of comparing performance with vs. without AI assistance for diagnostic accuracy. It was a usability and performance study evaluating the SentEP system when used by an operator alongside the traditional EAMS system. The study compared "the navigational capability of the SentEP system when compared to the EAMS system" and usability. It does not provide an effect size on how much human readers (operators) improve with SentEP vs. without SentEP because SentEP is an additional visualization modality and was used in conjunction with the EAMS, not as a replacement or direct comparison of diagnostic effectiveness. The evaluation was about whether the combination (EAMS + SentEP) was comparable in performance and safe.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance study was not done. The SentEP system is described as a "visualization modality to assist the clinician" and "does not deliver therapy, nor does it intervene with therapy." It is used with a human operator (Electrophysiologist) who interacts with the data, making it inherently a human-in-the-loop system. The clinical study specifically evaluated "SentEP system usability and performance during EP procedures" by an "operator."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used for the clinical study was based on:
- Navigational targets: Defined locations within the heart during EP procedures.
- Time allocation: 60 seconds per location, implying a time-based metric for successful navigation.
- Point location accuracy: The accuracy of reaching or identifying specific points, likely verified against the EAMS system data and the EP's procedural goals.
- User feedback: Physician Exit Survey responses for usability and comfort.
Essentially, the "ground truth" involved the actual anatomical and electroanatomic data provided by the EAMS system, combined with the real-time assessment of navigation and target achievement by the performing Electrophysiologist within the clinical procedure.
8. The sample size for the training set
The document does not provide information about the sample size for the training set. The clinical study described is for validation purposes, not for training the algorithm. As the device is primarily a visualization and interaction tool for existing electroanatomic data, it's possible that a traditional "training set" in the machine learning sense is not applicable or not disclosed as part of the regulatory submission summary provided.
9. How the ground truth for the training set was established
Since no information regarding a training set is provided, how its ground truth was established is also not detailed in this document.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of a human figure, while the FDA acronym is in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in a sans-serif font.
September 18, 2020
SentiAR, Inc Berk Tas Ceo and President 212 Kingshighway Blvd., Suite 115 Mailbox 28 St. Louis, Missouri 63108
Re: K192890
Trade/Device Name: SentEP system Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: August 17, 2020 Received: August 18, 2020
Dear Berk Tas:
We have reviewed vour 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,
Mark Fellman Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192890
Device Name SentEP system
Indications for Use (Describe)
The SentEP system is intended for use as a medical imaging system that allows the review, and media interchange of multi-dimensional digital images. It is also intended for intraprocedural use. The SentEP system is designed as an additional visualization modality to assist the clinician. The SentEP system is indicated for use in electrophysiology (EP) procedures to assist the clinician in visualization of the heart electroanatomic data.
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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SENTIAF
510(K) SUMMARY
1 SUBMITTER INFORMATION
| Date Prepared: | August 7, 2020 |
|---|---|
| Submitter's Nameand Address | SentiAR, Inc.212 N. Kingshighway Blvd., Suite 115Mailbox 28St. Louis, MO 63108Telephone: (314) 499-0552 |
| Contact Person: | Berk Tas, Chief Executive Officer |
2 DEVICE INFORMATION
| Name of MedicalDevice | Proprietary Name: SentEP systemCommon Name: Imaging software system |
|---|---|
| DeviceClassification | Classification Name: System, Image Processing RadiologicalRegulation Name: Picture archiving and communication systemRegulation Number: 21 CFR 892.2050Regulatory Class: Class IIProduct Code: LLZClassification Panel: Radiology |
| Device Description | The SentEP system is an imaging system intended to be used as anadjunct product to assist the clinician in visualization of the heartanatomy during cardiac catheter mapping and ablation procedures.Images are imported from an EAMS (electroanatomic mappingsystem) and displayed through the SentEP system. As a result, userscan view both the 2D EAMS display monitor and the 3D SentEPsystem display at the same time. |
3 PREDICATE/REFERENCE DEVICE INFORMATION
| PredicateDevice | Ceevra Reveal 2.0 cleared via K173274 on July 10, 2018 |
|---|---|
| ReferenceDevice | Abbott EnSite Velocity System cleared via K130594 on May 3, 2013 |
4 DEVICE DESCRIPTION
The SentEP system is a medical imaging system which allows for the review, analysis, communication, and media interchange of multi-dimensional digital images. Multi-dimensional images are imported from an Electroanatomic Mapping System (EAMS) which are then displayed by the SentEP system software to assist physicians in the visualization of heart electroanatomic data. The SentEP system Head Mounted Display (HMD) provides a view through, stereoscopic 3D view of the data, allowing the user to see the environment as well as the specific holographic image. The SentEP system software additionally provides a 2D view of the
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data on the Data Manager PC / Spectator Display for others not using the HMD. Components of the SentEP system are detailed in the table below.
| Component | Function |
|---|---|
| HMD | Used to display the anatomical hologram with real-time data. Used to provide the Operator with the ability to interact with data and images. The system is compatible with up to 5 HMDs in a single shared session |
| Data Manager PC/Spectator Display | Used to coordinate transmission of anatomical and real-time data between EAMS and HMDs and to provide a spectator display. |
| Enclosure | Used to provide network connectivity to EAMS, Data Manager PC/Spectator Display, and HMD |
| Cables | Used to provide power and network connectivity to components |
| Proprietary Software | Used to render the model and provide real-time data within the user interface |
An Electrophysiologist (EP) is the intended user of the SentEP system. The EP performs procedures in a cardiac electrophysiology laboratory, which is a sterile operating room located in a hospital or clinic. The SentEP system provides the EP with a mixed reality user interface design displayed through the HMD (a commercially available Microsoft HoloLens installed with proprietary software and provided as a component of the SentEP system). Supporting staff members can view the anatomical model on an additional CC display from the same perspective as the controlling EP, while the controlling EP manipulates the display on the HMD. The SentEP system is a non-patient contacting device and is provided non-sterile.
Manipulation of the current EAMS display requires relaying commands from the EP to a nurse or technician within the EP lab or between the EP lab and control room outside of the EP lab. The SentEP system provides the EP direct visualization and control of the EAMS output. The SentEP system does not provide control of the EAMS directly.
In summary, the SentEP system does not deliver therapy, nor does it intervene with therapy. It is intended to provide users with information to assist the clinician in visualization of the heart electroanatomic data.
5 INDICATIONS FOR USE
The SentEP system is intended for use as a medical imaging system that allows the review, analysis, communication, and media interchange of multi-dimensional digital images. It is also intended for intraprocedural use. The SentEP system is designed as an additional visualization modality to assist the clinician. The SentEP system is indicated for use in electrophysiology (EP) procedures to assist the clinician in visualization of the heart electroanatomic data.
6 COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The SentEP system has similar intended use and indications for use, principles of operation, and technological characteristics as the legally marketed predicate device.
- . Both devices are intended as medical imaging systems that allow the review, analysis, communication, and media interchange of multi-dimensional digital images.
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- . Both devices support viewing 3D digital images on a head mounted display.
- Both devices are intended for intraprocedural use by healthcare professionals.
- Both devices are provided non-sterile and are not intended to be sterilized. ●
- Both devices are biocompatible for their intended use. .
Differences between the SentEP system and the predicate device have been evaluated for impact to safety and performance. Primary differences between the SentEP system and the predicate device are identified below.
- . The SentEP system is intended only for intraprocedural use. The predicate device is intended for both preprocedural and intraprocedural use. The SentEP system intended use is a subset of the predicate device intended use, which does not raise any different questions of safety and effectiveness.
- The source data for the SentEP system is derived from the reference device. The . predicate device uses a DICOM protocol to generate the 3D dimensional images. While the proposed and predicate devices use different communication protocols, both the SentEP system and the predicate device offer proprietary software for the same purpose of displaying anatomical image data in 3D format, and therefore do not raise any different questions of safety and effectiveness.
- The SentEP system processes streaming live data (dynamic) collected in real-time. The . predicate device can process either historical static images or historical dynamic recordings. Both devices process dynamic images that provide the ability to view the data for the intended purpose of each of the devices, and therefore the difference does not raise any different questions of safety and effectiveness.
Although the SentEP system and the predicate device technological characteristics differ in the preprocedural use, communication source, and image data format, performance testing has demonstrated that the SentEP system is as safe and effective as the predicate and that the differences do not raise any different questions concerning safety and effectiveness. The implemented design controls, risk management activities, labeling, and performed verification and validation tests demonstrate the safety and performance of the SentEP system. Based on the comparison information provided above. it is concluded that the SentEP system is substantially equivalent to the predicate device.
7 PERFORMANCE DATA
Verification and validation testing data summarized below were provided in support of the substantial equivalence determination.
Non-Clinical Performance Testing:
Non-clinical performance testing included an evaluation of biocompatibility, mechanical testing, electromagnetic compatibility and electrical safety, wireless capability, and human factors testing.
The safety and performance of the SentEP system have been evaluated and verified according to the specified standards. Verification and validation testing have demonstrated compliance to the software specifications and performance standards. The SentEP system demonstrates conformance specifically to:
- IEC 62304:2006/AC: 2008- Medical device software Software life cycle processes ●
- IEC 60601-1:2005 Ed.3+C1; C2 Medical Electrical Equipment Part 1: General . requirements for basic safety and essential performance
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SENTIAR
- . IEC 60601-1-2 ed 4.0 (2014-02) Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
Clinical Study:
A clinical study was completed to assess SentEP system usability and performance during EP procedures. The clinical study was a prospective, acute, single center study of 16 pediatric EP patients representing the intended patient population (age 7.3-19.4, 6 males-10 females, 3 ethnicities represented). The study was performed in the United States.
The purpose of this study was to evaluate both the navigational capability of the SentEP system when compared to the EAMS system and the usability of the SentEP system by assessing the user comfort of the device. EP procedures were performed in accordance with normal standard of care for the condition being treated. For a portion of the procedure, the operator had the electroanatomic imaging information displayed on the SentEP system HMD in addition to the traditional EAMS system display while navigating to intended targets.
The equivalency between the SentEP system and the EAMS system was evaluated by comparing: 1) the ability to navigate to 5 locations within allocated time (60s per location), 2) point location accuracy and 3) Physician Exit Survey responses. No adverse events were reported during this study. The comparison of the performance data and safety data collected support the conclusion that the SentEP system was found to have a safety and effectiveness profile that is similar to the legally marketed EAMS system.
8 SAFETY AND PERFORMANCE CONCLUSION
Non-clinical and clinical performance testing demonstrated that the SentEP system is as safe and effective as the legally marketed predicate and reference devices. Based on evidence submitted in this premarket notification, including similarities in the indications for use, technological characteristics, and performance between the SentEP system and the predicate and reference devices, the SentEP system raises no new questions of safety or effectiveness and is substantially equivalent to the predicate device.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).