Search Results

The Bard LabSystem™ EP Laboratory is a computer and software driven data acquisition and analysis tool designed to facilitate the gathering, display, analysis by a physician, pace mapping and storage of cardiac electrophysiologic data.

When integrated with the Philips EP navigator system, the BARD® LabSystem™ PRO EP Recording System is designed to acquire, analyze, and display 3D electroanatomical maps of the human heart. The maps are constructed using intracardiac electrograms with their respective cardiac locations taken from live x-ray overlay on a patient's 3D cardiac anatomy. Maps may be displayed as electrical activation maps, voltage maps, dominant frequency maps and location maps with user defined measurement values.

The LabSystem EP Recording System is a microprocessor based data acquisition system that is used during electrophysiology procedures to acquire ECG, intracardiac, pressure and digital data from other devices like fluoroscopic systems and RF generators. The ECG, intracardiac and pressure data are acquired by an amplifier that is connected to the patient.

The provided document is a 510(k) Summary for the Bard LabSystem™ PRO EP Recording System, specifically for its V3.1 software. It focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about a study proving device performance against specific acceptance criteria. This type of regulatory submission typically relies on a comparison to existing, legally marketed devices rather than presenting novel performance studies with acceptance criteria, especially for software updates to established systems.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, and expert involvement are not present in this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Not available in the document. The document does not describe specific acceptance criteria or report quantified device performance metrics (e.g., sensitivity, specificity, accuracy) for the V3.1 software. The submission aims to show "substantial equivalence" to predicate devices, implying that its performance is comparable, but it doesn't present a study with specific targets.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not available in the document. There is no mention of a test set, its sample size, or the provenance of the data.

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)

• Not available in the document. Given no test set is described, there's no information on experts establishing ground truth for it.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not available in the document. No information on an adjudication method for a test set is provided.

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/Not available in the document. This device is an EP recording system for acquiring, analyzing, and displaying cardiac electrophysiologic data and 3D electroanatomical maps during electrophysiology procedures. It does not appear to be an AI-driven diagnostic system that assists human readers in the way an MRMC study typically assesses for AI. The document does not describe any MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable/Not available in the document. The device is a "computer and software driven data acquisition and analysis tool" that "facilitate[s] the gathering, display, analysis by a physician." It is inherently designed for use by a physician, not as a standalone, fully autonomous diagnostic algorithm. No standalone performance study is mentioned.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not available in the document. Since no specific performance study or test set is described, there's no information on the type of ground truth used.

8. The sample size for the training set

• Not available in the document. This document does not discuss a training set. The device appears to be a software update for an existing system, and the submission emphasizes regulatory compliance and substantial equivalence rather than a machine learning model's training and validation process.

9. How the ground truth for the training set was established

• Not available in the document. Since no training set is mentioned, there's no information on how its ground truth was established.

Summary of Non-Clinical Testing Section (Relevant to the overall submission but not specific performance metrics):

The document states: "The LabSystem™ PRO EP Recording System is developed and produced in accordance with 21 CFR 820.30 Quality System Regulations. The software product is developed and tested in accordance with the following industry standards." While this indicates quality control and development processes, it doesn't provide specific device performance acceptance criteria or study results against those criteria. The "Summary of Non-Clinical Testing" is a high-level statement about adherence to quality systems and standards, rather than a detailed report of a performance study.

Ask a specific question about this device

The Biosense Webster SOUNDSTAR™ 3D Ultrasound Catheter and related accessory devices are indicated for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. When used with the CARTO® XP EP Navigation System Version 9 or greater, the SOUNDSTAR" 3D Ultrasound Catheter provides location information.

The Biosense Webster SOUNDSTAR" 3D Ultrasound Catheter is a 90 cm 10F IntraCardiac Echo (ICE) Catheter with an acoustic array identical to the ACUSON AcuNav 10F Diagnostic Ultrasound Catheter. The catheter has a location sensor (providing location information to the CARTO® EP XP Navigation System Version 9 - 510(k) submitted separately) and an ultrasound transducer (acquiring real time ultrasound images) embedded in the tip.

The SOUNDSTAR™ 3D Ultrasound Catheter has a bifurcated 'tail' originating from its handle (see Figure 1). One leg terminates in the SOUNDSTAR tab connector, which connects via a Swiftlink™ cable to an ultrasound system (ACUSON) Sequoia " Ultrasound System of the and 510(k) K052331 respectively). The other leg terminates in the CARTO Hypertronic connector, which connects via a Patient Interface Unit (PIU) extension cable to the CARTO® XP EP Navigation System Version 9 (510(k) submitted bundled with the SOUNDSTAR 31) Ultrasound Catheter submission).

The Sequoia and Cypress Ultrasound Systems were designed to acquire two dimensional (2D) ultrasound (U/S) images and display them. The SOUNDSTAR" 3D Ultrasound Catheter connects to either of these ultrasound systems via the appropriate SwiftLink connector cable. The U/S images are Vector" images for wide angle viewing of the heart anatomy. These systems are used to image the anatomy of the heart and also visualize blood flow through Doppler imaging. They are also used to visualize other catheters and devices in the heart.

The imaging software in the Sequoia and Cypress U/S systems that currently drives AcuNav Catheters will be the same software that drives the SOUNDSTAR" 3D Ultrasound Catheter.

The acoustic array used in the SOUNDSTAR™ 3D Ultrasound Catheter is identical to the acoustic array currently used in the AcuNav Catheter.

The CARTO® XP EP Navigation System Version 9 is designed to acquire. analyze, and display electro-anatomical maps of the human heart. The maps are reconstructed using the combination of information gathered from the integration of intracardiac electrograms with their respective endocardial locations. Maps may be displayed as electrical activation maps, electrical propagation maps, electrical potential maps, impedance maps and chamber geometry maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real-time on the display screen.

The SOUNDSTAR™ 3D Ultrasound Catheter is compatible with the CARTO® XP EP Navigation System Version 9, (Version 8 cleared under 510(k) K042999).

The SOUNDSTAR™ 3D Ultrasound Catheter, when connected to the CARTO® XP EP Navigation System Version 9, and the Sequoia or the Cypress Ultrasound Systems, will provide real-time integration of ultrasound images with CARTO electromagnetic acquired maps.

The SoundStar 3D Ultrasound Catheter underwent extensive non-clinical studies to establish its substantial equivalence to predicate devices, namely the ACUSON AcuNav 10F Diagnostic Ultrasound Catheter and the Biosense Webster NAVISTAR Diagnostic catheter.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided text states that the device "passed all intended criteria in accordance with appropriate acceptance criteria and standards" for extensive bench and electrical testing. However, specific quantitative acceptance criteria and detailed performance metrics are not explicitly provided in the given document. The information outlines the general areas of performance that were evaluated.

• Intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology.
• Visualization of other devices in the heart.
• Acquisition of location information for CARTO mapping. |
  | Equivalence to Predicate Devices| The studies establish equivalence of the SOUNDSTAR™ 3D Ultrasound Catheter to the predicate devices, the NAVISTAR Diagnostic catheter and the AcuNav 10F Ultrasound Catheter. This implies that its performance in the key areas listed above is comparable to or better than the legally marketed predicate devices. |
  | Simulated Use Conditions | The SOUNDSTAR™ 3D Ultrasound Catheter was also tested under simulated use conditions in animals. (This implies successful operation and performance in a physiological environment that mimics human use, though specific outcomes are not detailed). |

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

• Sample Size: Not specified. The document mentions "extensive bench and electrical testing" and "simulated use conditions in animals" but does not quantify the number of units tested or the number of animals used.
• Data Provenance: The studies were non-clinical, implying they were conducted in a controlled environment (bench testing) and an animal model. The country of origin for the data is not specified, but the applicant and manufacturer are based in the USA. The studies are prospective in nature, as they are conducted for the purpose of demonstrating device performance prior to market clearance.

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

This information is not provided in the document. As this is a traditional 510(k) for a hardware device focused on substantial equivalence to existing technology, it's unlikely a formal expert-driven ground truth establishment process (as seen in AI/imaging diagnostic devices) was explicitly documented in this summary. The "ground truth" for electrical and bench testing would rely on established engineering specifications and measurement standards, and for animal studies, it would be based on physiological observations and established medical assessment methods.

4. Adjudication Method for the Test Set:

This information is not provided. Given the nature of the device (hardware/catheter), an adjudication method for test results as typically described for diagnostic algorithms (e.g., 2+1, 3+1 for discrepancies) is not directly applicable. Performance would likely be assessed against predetermined pass/fail criteria on a per-test basis.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not explicitly mentioned or implied. This type of study is more common for diagnostic imaging algorithms where human reader performance is a key metric. The focus here is on the device's physical and functional equivalence to predicate devices, and its ability to provide clear visualization and location information.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

The device itself is a "Diagnostic Ultrasound Catheter" and an "Electrophysiologic Mapping/Ultrasound Catheter." It provides real-time ultrasound images and location information for human interpretation and use within a larger system (CARTO XP EP Navigation System). Therefore, its performance is inherently linked to human-in-the-loop operation, as it generates data for human clinicians to act upon. While individual components (like the acoustic array) underwent standalone testing, the complete device is designed for human interaction. The summary focuses on the device's ability to "acquire real-time ultrasound images" and "provide location information," which are standalone functions of the algorithm/hardware working.

7. The Type of Ground Truth Used:

• Bench and Electrical Testing: Ground truth would be based on engineering specifications, established measurement standards, and physical principles. For example, electrical impedance measurements would be compared against a known standard or internal specification.
• Animal Studies: Ground truth would be established through physiological observations, direct visualization during the procedure, and potentially post-mortem examination or correlation with other established diagnostic methods.
• Equivalence to Predicate Devices: The primary "ground truth" for equivalence is the performance and characteristics of the legally marketed predicate devices, against which the SoundStar 3D Ultrasound Catheter was compared.

8. The Sample Size for the Training Set:

This question is not applicable in the context of this traditional 510(k) for a physical medical device. "Training set" typically refers to data used to train an artificial intelligence or machine learning algorithm. This submission describes a hardware device with an acoustic array (identical to a predicate device) and a location sensor. There's no indication of AI or machine learning being used in a way that would require a "training set" in the conventional sense. The "imaging software" in the ultrasound systems that drives the catheter is the same as that used for the predicate, suggesting no new algorithm development requiring a training set for this specific device.

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

This question is not applicable for the same reasons as point 8. No training set for an algorithm is mentioned in the filing.

Ask a specific question about this device