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V5Ms trans-esophageal echocardiograph (TEE) ultrasound transducer is intended primarily for cardiology applications.

ACUSON Antares Ultrasound System: The Acuson Antares ultrasound imaging system is intended for the following applications: Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Intracardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculoskeletal. Great Vessel, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

ACUSON CV70 Cardiovascular System: The CV70 ultrasound imaging system is intended for the following applications: Abdominal. Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Intracardiac, Transesophageal, Pelvic, Neonatal/Adult Gephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculoskeletal, Great Vessel, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

ACUSON Cypress Ultrasound System: The Cypress platform is intended for use in the following applications: General Imaging and Cardiology for Fetal. Abdominal. Intraoperative (cardiac), Pediatrics, Neonatal Cephalic, Cardiac (adult, pediatric), Trans-esophageal, Peripheral Vessel, Intraluminal and Intra-cardiac applications, and intended uses as defined in the FDA quidance document. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes

ACUSON S1000/S2000 Ultrasound System: The S2000™ ultrasound imaging systems are intended for the following applications: Fetal. Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal(conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging."

ACUSON SC2000 Ultrasound System: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The typical examinations performed using the SC2000 Ultrasound System are: Cardiac Imaging Applications and Analysis, Vascular Imaging Applications and Analysis, Superficial Imaging Applications, Intraoperative Imaging Applications, Transcranial Imaging Applications.

ACUSON Sequoia Ultrasound System: The Siemens ACUSON Sequoia ultrasound imaging system is intended for the following applications: General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid and penis), Neonatal/Adult Cephalic, Cardiac (adult, pediatric, and neonatal), Trans-esophageal, Transrectal, Transvaginal, Peripheral Vessel, and Musculo-sceletal (superficial and conventional) applications, and intended uses as defined in the FDA quidance document. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

ACUSON X300 Ultrasound System: The Siemens ACUSON X300 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides measurement of anatomical structures and analysis packages that provide information that is used for clinical diagnosis purposes. The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients reqarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement: Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".

The V5Ms Transesophageal Transducer consists of a gastroscope control housing where nosepiece articulation and transducer rotation are controlled. A flexible transesophageal guide tube with a nosepiece containing the acoustic array extends from one end of the control housing and the system cable/connector extends from the other end. The acoustic array has 64 elements and rotates 180 degrees to provide imaging planes from transverse view to inverse transverse view. Rotation is powered by a motor in the control housing and is controlled by the operator using a switch button on the control housing for clockwise and counterclockwise rotation. Nosepiece articulation is achieved by manipulating a vertebrae section adjacent to the nosepiece through a series of control wires attached to knobs on the control housing. The nosepiece can be articulated in both the anterior/posterior and left/right directions.

Here's a breakdown of the requested information, based on the provided document:

Acceptance Criteria and Study Details for V5Ms Transesophageal Transducer

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) submission document does not explicitly state quantitative acceptance criteria or specific device performance metrics in the way one might expect for a new or significantly modified device. Instead, the submission relies heavily on substantial equivalence to a previously cleared predicate device (Siemens V5Ms Transesophageal Transducer, K052021). The key "performance data" presented is that "Performance data is not required for this modification as there is no change to software or hardware." This implies that the device is expected to perform identically to its predicate because the changes are limited to patient contact materials.

Therefore, the acceptance criteria are implicitly met by demonstrating that the modifications do not negatively impact the established performance of the predicate device.

Implicit Acceptance Criteria and Reported Performance (Based on Substantial Equivalence):

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

• Sample Size for Test Set: Not applicable (N/A). The document explicitly states, "Performance data is not required for this modification as there is no change to software or hardware." Therefore, there was no clinical performance test set used. The evaluation centered on non-clinical tests for biocompatibility and asserting substantial equivalence.
• Data Provenance: N/A for clinical performance data. For biocompatibility testing, the data would typically originate from a laboratory (likely in the USA or a facility that adheres to international standards like ISO). The origin is not specified beyond "Nonclinical tests contained in this submission include biocompatibility testing per ISO10993-1 (cytotoxicity, sensitization, irritation)."

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

• N/A. As no clinical performance test set was conducted, there was no need for experts to establish ground truth. The primary "experts" involved in the submission would be Siemens' own regulatory and engineering teams, and subsequently, FDA reviewers.

4. Adjudication Method for the Test Set

• N/A. Since no clinical performance test set was conducted, no adjudication method was used.

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

• No. No MRMC study was conducted. The submission is a 510(k) for substantial equivalence based on minor modifications (patient contact materials) to an existing device, not a new clinical effectiveness study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• N/A. The device is a diagnostic ultrasound transducer, not an AI algorithm. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply.

7. The Type of Ground Truth Used

• N/A for clinical effectiveness. For biocompatibility, the "ground truth" is defined by the ISO10993-1 standard for cytotoxicity, sensitization, and irritation. This involves standardized biological tests.

8. The Sample Size for the Training Set

• N/A. This device is a hardware component (transducer) and does not involve machine learning or AI, and therefore does not have a "training set."

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

• N/A. As there is no training set for this device, this question is not applicable.

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The Elettra Ultrasound System is intended for diagnostic imaging or fluid flow analysis of the human body including: Fetal, Abdominal, Intraoperative, Intraoperative Neurological, Pediatric, Small Organ, Neonatal Cephalic, Cardiac, Peripheral Vessel, Musculoskeletal (Conventional), Musculoskeletal (Superficial).

The Penrith Elettra is a compact diagnostic ultrasound device. It includes a system console housing electronic circuitry, a video display, power supply, and user controls. This connects to the transducers and together these generate the ultrasound image.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Penrith Elettra Diagnostic Ultrasound System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary (K100598) is a premarket notification for a diagnostic ultrasound system. For this type of device, the primary "acceptance criteria" for clearance through the 510(k) pathway is demonstrating substantial equivalence to a predicate device. This means the device is as safe and effective as a legally marketed device.

Therefore, the acceptance criteria are implicit:

• The device must perform in a manner substantially equivalent to predicate devices.
• The device must meet applicable medical device safety standards for acoustic output, biocompatibility, cleaning, disinfection, sterilization, thermal, electrical, mechanical safety, and electromagnetic compatibility.
• All claimed indications for use must be covered by the predicate devices.

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

This document describes a 510(k) premarket notification for an ultrasound system, which primarily relies on demonstrating substantial equivalence to predicate devices, rather than a clinical study comparing the device to a "gold standard" or a control group.

• No specific "test set" sample size is mentioned in the document for performance comparison in a clinical trial sense. The evaluation for substantial equivalence is based on technical, functional, and safety comparisons to already cleared devices.
• Data provenance: Not applicable in the context of a prospective clinical "test set" as none is detailed. The performance claims are backed by adherence to standards and comparison of specifications to predicate devices.

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

• Not applicable. The document does not describe a clinical study involving a test set with expert-established ground truth. The "ground truth" for a 510(k) submission like this is the established safety and effectiveness of the predicate devices and the adherence to relevant medical device standards.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set and no expert adjudication process are described in this 510(k) summary.

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

• No. The document does not mention any MRMC comparative effectiveness study. This type of study is more common for AI/CADe devices that assist human readers in interpretation. The Penrith Elettra is a diagnostic imaging system itself, not an AI interpretation tool.

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

• Not applicable. The Penrith Elettra is a diagnostic ultrasound system, not an AI algorithm. Its "standalone performance" is its ability to generate images and perform measurements, which is assessed through technical evaluation and comparison to predicate devices, rather than a specific algorithm-only study. The document states it was "evaluated for acoustic output, biocompatibility, cleaning, disinfection, and sterilization effectiveness, as well as thermal, electrical and mechanical safety, and electromagnetic compatibility."

7. The Type of Ground Truth Used

• For the purpose of this 510(k) submission, the "ground truth" is primarily:
  • The established safety and effectiveness of the identified predicate devices (Acuson Sequoia K022567, Acuson Cypress K052331, Philips Avalon CTS K023931).
  • Compliance with recognized medical device safety and performance standards (e.g., Track 3 method for acoustic output, electrical/physical safety standards).

8. The Sample Size for the Training Set

• Not applicable. This document describes a traditional diagnostic ultrasound system, not an AI/machine learning device that requires a training set.

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

• Not applicable. As no training set is involved for this device, there is no ground truth establishment for a training set.

In summary: The provided document is a 510(k) premarket notification for a diagnostic ultrasound system. It demonstrates safety and effectiveness by establishing substantial equivalence to existing, legally marketed predicate devices through technical comparisons, adherence to standards, and matching indications for use. It does not involve a clinical study with specific test sets, expert ground truth development, or AI algorithm performance evaluation the way a more modern AI/CADe submission might.

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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.

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